FDA/USDA August ~2019~ Alerts & Safety


  • Krasnyi Oktyabr USA Inc of Brooklyn, NY is recalling its 500gram (17.65oz) packages of TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

    The recalled “TAINY VOSTOKA ASSORTED DRIED FRUITS APPLE” were distributed nationwide in retail stores and through mail orders. The product comes in 500gram (17.65 oz), clear plastic package marked with container code #15 03 2019 SS.

    No illness or allergic reactions involving this product have been reported to date.

    The recall was initiated after routine sampling be New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 500gram (17.65oz) packages of “TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE” which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individual upon ingesting 10 milligrams or more of sulfites. Analysis of the “TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE” revealed they contained 23.69 mg per serving.

    Consumers who have purchased 500gram (17.65oz) packages of “TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE” are urged to return them to the place of purchase for full refund. Consumers with questions may contact the company at 718-858-6720.

    Link to Krasyni Qunice Recall

  • 084-2019,  Tyson Foods, Inc. Recalls Weaver Brand Ready-To-Eat Chicken Patty Products due to Possible Foreign Matter Contamination (Aug 15, 2019)
  • Sterile Compounded Drug Products by AmEx Pharmacy: Recall – FDA requests recall of sterile compounded drug products and reminds patients and health professionals to stop using due to potential risks AUDIENCE: Eye Care, Patient, Health Professional, Risk Manager, Pharmacy, ConsumerISSUE: An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. Administration of a non-sterile drug intended to be sterile presents the risk of infection. Intraocular medications which are not sterile can lead to intraocular infections such as endophthalmitis which, depending on the infecting microorganism, can lead to a loss of partial or total permanent visual function (i.e., no light perception).
  • Olympia Meats, a Portland, Ore., establishment is recalling approximately 198 pounds of ready-to-eat (RTE) pork sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains pistachios (tree nuts), a known allergen, which is not declared on the product label.

    The RTE pork sausage products are labeled as “Mortadella Classica” products but contain Mortadella Pistachio sausage products. The items were produced on July 29, 2019.

    The following products are subject to recall: [View Label]

    • Varying weights of vacuum packed “OLYMPIA PROVISIONS MORTADELLA CLASSICA WITH GARLIC AND SPICES” with a best by date of l2-30-2019.

    The products subject to recall bear establishment number “Est. 39928” inside the USDA mark of inspection. These items were shipped to retail locations in California, Oregon, and Washington.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider .          Consumers with questions about the recall can contact Alexis Heimlich, at (503) 894-8275 or alexis@olympiaprovisions.com. Members of the media with questions about the recall can contact Megan Moran, at (503) 894-8275 or megan@olympianprovisions.com.

 

  • Makzemo LLC of Brooklyn, NY is recalling Balquis Yemeni spice, because it has the potential to be contaminated with lead.Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water.Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.Balquis Yemeni spice was distributed in Michigan and the five boroughs of New York through retail supermarkets and grocery stores.

    The spice is packaged in clear plastic containers, 230 grams and 454 grams and in clear 5 lb plastic bags.

    The product is yellowish/brown in color.

    The brand name is Balquis.

    No injuries or illness are associated with this product.

    The recall was a result of the New York City Department of Health circulating a flyer about the product and visiting a few retail stores and informing them of the findings.

    The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

    Consumers who have purchased Balquis Yemeni spice in clear plastic containers 230 grams/454 grams or 5 lb plastic bags are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 917-444-2211 Monday through Friday, 9am-5pm EST.

  • Mountain Mel’s Essential Goods, LLC of Welches, OR is recalling The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and Diges-Teas Herbal Tea with LOT # DT7619100, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The Milk Lady’s, Peaceful Baby, and Diges-Teas were distributed in Oregon and Washington through New Seasons Market, and nationwide through Azure Standard, Mountainmels.com and Amazon.com. The affected tea products were distributed by Mountain Mel’s Essential Goods June 27, 2019 and July 20, 2019.The Milk Lady’s Herbal Tea Blend, UPC 7 99632 05658 4, is packaged in a tall thin tin container with 2 oz of tea per tin, with a purple label. The LOT# of the recalled batch is # ML6271950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Milk Lady’s Tea is listed as 7/2021.Peaceful Baby Herbal Tea Blend, UPC 7 99632 05656 0, is packaged in a tall thin tin container with 2 oz of tea per tin, with a blue label. The LOT# of the recalled batch is #PB781950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Peaceful Baby Tea is listed as 7/2021.Diges-Teas Herbal Tea Blend, UPC 7 99632 05665 2, is packaged in a tall thin tin container with 2 oz of tea per tin, with a brown label. The LOT# of the recalled batch is #DT7619100. The LOT# can be located on the bottom of the tin package. The Best By Date of the Diges-Teas Herbal Tea is listed as 7/2021.No illnesses have been reported to date.

    This recall was initiated because the herbal teas were made with the recalled fennel seed whole that was supplied and recalled by Mountain Rose Herbs in Oregon. Mountain Mel’s Essential Goods has ceased production and distribution of this product as of July 20, 2019.

    This recall is being made with the knowledge of the U.S. Food and Drug Administration.

    Consumers who have purchased Mountain Mel’s The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and/or Diges-Teas Herbal Tea with LOT # DT7619100 are urged to take a photo of the product and lot label, email that to info@mountainmels.com for a full refund.

  • Heatherfield Foods, Inc., an Ontario, Calif. establishment, is recalling approximately 4,380 pounds of pork sausage products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product has a gluten free claim represented on the front of the label; however, the product contains gluten in the form of wheat. Wheat, which is an allergen, is also listed in the product’s list of ingredients.

    The raw Longanisa sausage items were produced on various dates between March 8, 2019 and July 31, 2019. The following product is subject to recall: [View labels (PDF only)]

    • 1-lb. thermoform tray packages containing “HAWAIIAN SAUSAGE COMPANY Sweet Filipino Longanisa ˙NO PRESERVATIVES ˙GLUTEN FREE ˙NO MSG” with lot codes 09067, 09081, 09088, 09113, 09130, 09148, 09156, 09163, 09170, 09179, 09193 and 09212 on the label.

    The products subject to recall bear establishment number “EST. 4846” inside the USDA mark of inspection. These items were shipped to retail locations in Hawaii.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  Consumers and members of the media with questions about the recall can contact John Brown, Vice President, Heatherfield Foods Inc., at (909) 460-4150.

  • American Beef Packers, Inc., a Chino, Calif. establishment, is recalling approximately 24,428 pounds of raw beef products that are deemed unfit for human consumption, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

    FSIS inspection personnel retained the carcass and collected a sample for further analysis. Prior to test results being received, the carcass was erroneously released and further processed into raw intact and non-intact beef products, which were distributed in commerce.

    The raw beef items were produced and packaged on Aug. 21, 2019.

    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 85 BONELESS BEEF CHUCKS” with LOT NO.110 and BIN No. 85 and BIN No. 86.
    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 90 BONELESS BEEF” with LOT NO. 110 and BIN No. 81, BIN No. 82 and BIN No. 83.
    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 85 BONELESS BEEF” with LOT NO. 25-110 and BIN No. 84 and LOT NO 110 and BIN No. 88.
    • Cases containing “AMERICAN BEEF PACKERS RIBEYE 8/10 #1” with codes BT190821-1178, BT190821-1185, BT190821-1188, BT190821-1190, and BT190821-1194.
    • 66.2-lb. case containing “AMERICAN BEEF PACKERS RIBEYE 10 UP #1” with code BT190821-1186.
    • Bulk pack combo bin containing “AMERICAN BEEF PACKERS 90 BONELESS BEEF SIRLOINS” with LOT NO. 24-110 and BIN No. 80.
    • Cases containing “AMERICAN BEEF PACKERS TERDERLOIN 4 UP” with codes BT190821-1160, BT190821-1161, BT190821-1162, BT190821-1163, BT190821-1167, BT190821-1168, BT190821-1169, and BT190821-1170.
    • Cases containing “AMERICAN BEEF PACKERS RIBEYE 10 UP” with codes BT190821-1187 and BT190821-1192.
    • Cases containing “AMERICAN BEEF PACKERS TENDERLOIN 3/4” with codes BT190821-1155, BT190821-1157, BT190821-1171, BT190821-1200, BT190821-1201, BT190821-1202, BT190821-1203, BT190821-1204, and BT190821-1205.
    • 50-lb. cases containing “AMERICAN BEEF PACKERS DESC: BEEF FOR FURTHER PROCESSING 75/25” with lot code 08347412719.

    The products subject to recall bear establishment number “EST. 34741” inside the USDA mark of inspection. These items were shipped to federal establishments in California and Oregon.

    The firm notified FSIS on Aug. 30, 2019 that a carcass that was pending laboratory results had been erroneously released and further processed into raw intact and non-intact beef products.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

 

Hepatitis C Medicines [Mavyret (glecaprevir and pibrentasvir), Zepatier (elbasvir and grazoprevir), and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)]: Drug Safety Communication – Rare Occurrence of Serious Liver Injury in Some Patients with Advanced Liver Disease

AUDIENCE: Gastroenterology, Infectious Disease, Health Professional, Patient, Pharmacy

ISSUE: FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat

chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

FDA identified 63 cases of worsening liver function called liver decompensation with regimens Mavyret, Zepatier, and Vosevi to treat Hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.

RECOMMENDATION: Health professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A).

Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation. Vosevi is indicated for patients who have previously failed certain other Hepatitis C Virus treatments and is not recommended in patients with any history of hepatic decompensation unless the benefits outweigh the risk of liver injury, liver failure or death.

Patients should be aware that the risk of serious liver injury is rare. However, patients should contact a health professional right away if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

  • Update * Bakkavor Foods USA, Inc., a San Antonio, Texas establishment, is recalling approximately 1,913 pounds of ready-to-eat (RTE) chicken salad products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains pecans (tree nut), a known allergen, which is not declared on the product label.

    The RTE chicken salad products are labeled as “Curry Chicken Salad” products but contain Tarragon Chicken Salad products.  The items were produced on August 20, 2019.

    The following products are subject to recall [View Labels (PDF only)]:

    • 12 oz.  clear plastic squared containers of “SIMPLY EAT HEB MEAL SIMPLE CURRY CHICKEN SALAD” with a best by date of 08/28/2019.

    The products subject to recall bear establishment number “P-46445” inside the USDA mark of inspection. These items were shipped to a chain of retail grocery locations in Texas.

    The problem was discovered by the company during a review of production records.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

  • Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Veterinary ophthalmic drug products and lots, within expiry, identified below. This recall is only for the specific lots listed. No other lots are being recalled.Altaire is initiating the recall due to concerns regarding some QA controls in the manufacturing facility. The recalled products will be evaluated as part of Altaire’s review. As of this date, Altaire is pleased to state that they have not received any reports of adverse events from the use of the recalled products and lot #’s.Product Description: Vetropolycin Ophthalmic Ointment NDC Number: 17033-028-38  Package Size: 3.5 gm  Lot #:/ Exp. Date: 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (01/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ  (01/2), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21).Product Description: Vetropolycin HC Ophthalmic Ointment NDC Number: 17033-030-88 Package Size: 3.5 gm Lot #:/ Exp. Date: 17243/RHF (08/19), 17324/RJQ (10/19), 17326/RKA (11/19), 17327/RKB (11/19), 17328/RKC (11/19), 17389/RLN (12/19), 18013/SAH (01/20), 18028/SAQ (01/20), 18039/SBD (02/20), 19118/TDK (04/21).Product Description: Puralube Vet Ophthalmic Ointment NDC Number:  17033-211-38  Package Size: 3.5 gm Lot #:/ Exp. Date: 17246/RHH (08/19), 17265/RHQ (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (018/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ (01/21), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21)The products are manufactured and labeled exclusively for Dechra Veterinary Products. Altaire ships the products only to Dechra Veterinary Products. The products are distributed by Dechra Veterinary Products.Altaire has notified Dechra by e-mail on August 22, 2019 announcing the recalls of the products/lots identified herein, with specific directions to recall all units of the impacted lots. Altaire has also asked  Dechra to notify their downstream supply chain partners of the recall, and perform a sub-recall to the retail level.Dechra customers with questions regarding this recall can contact Dechra directly by calling 1-866-933-2472, or e-mailing support@dechra.com. Pet Owners should contact their veterinary care provider if they have any questions.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Center for Veterinary Medicine (CVM) program by using FORM FDA 1932a “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report” as follows:
    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

  • Olympia Meats, a Portland, Ore., establishment is recalling approximately 198 pounds of ready-to-eat (RTE) pork sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains pistachios (tree nuts), a known allergen, which is not declared on the product label.

    The RTE pork sausage products are labeled as “Mortadella Classica” products but contain Mortadella Pistachio sausage products. The items were produced on July 29, 2019.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  Consumers with questions about the recall can contact Alexis Heimlich, at (503) 894-8275 or alexis@olympiaprovisions.com. Members of the media with questions about the recall can contact Megan Moran, at (503) 894-8275 or megan@olympianprovisions.com.

    The products subject to recall bear establishment number “Est. 39928” inside the USDA mark of inspection. These items were shipped to retail locations in California, Oregon, and Washington.            Varying weights of vacuum packed “OLYMPIA PROVISIONS MORTADELLA CLASSICA WITH GARLIC AND SPICES” with a best by date of l2-30-2019.

  • Tip Top Poultry, Inc., a Rockmart, Ga. establishment, is recalling approximately 135,810 pounds of fully cooked poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, diced, and mechanically separated ready to eat chicken was produced on January 21, 2019 and display “PACK DATE 01/21/19” on the labels. The products subject to recall can be found in this spreadsheet. [View labels (PDF only)]
The products subject to recall bear establishment number “P-17453” inside the USDA mark of inspection or on the case. These items were shipped to hotels, restaurants, and institutions nationwide.
The problem was discovered on August 17, 2019, when the Canadian Food Inspection Agency (CFIA) notified FSIS that a sample of product produced by Tip Top Poultry, Inc. confirmed positive for the presence of Listeria monocytogenes.
Canadian public health and food safety partners, including the Public Health Agency of Canada and the Canadian Food Inspection Agency, have been investigating an outbreak of Listeria monocytogenes. A ready-to-eat diced chicken product collected as part of the investigation tested positive for Listeria monocytogenes. The investigation is ongoing.Media and consumers with questions regarding the recall can contact Terry Bruce, Senior V.P., Operational Quality, Tip Top Poultry, at (770) 973-8070.

  • AWERS, Inc. of Bellevue, WA is recalling Grained Salmon Caviar 95g (Sockeye Salmon Caviar) with “BEST BEFORE OCT 07 2020”, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
    Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
    Grained Salmon Caviar 95g was distributed in California, New York, Oregon, Washington and product may have further distributed to other states and Canada.
    Product is packed in a metal tin with Cyrillic lettering. The tin is green, with red and white writing with an easy open pull lid. The “BEST BEFORE OCT 07 2020” is printed on the bottom on the tin (See attached photo).
    No illnesses have been reported to date.
    The product was reviewed by the Canadian Food Inspection Agency (CFIA) and sent to a lab for testing. The analysis showed a lower than normal salt content, which can foster an anaerobic environment which is necessary to breed the Clostridium botulinum bacteria. No Clostridium botulinum bacteria was detected in product.
    This recall is being made with the knowledge of the U.S. Food and Drug Administration.
    Consumers must inform AWERS, Inc. if they possess any Grained Salmon Caviar 95g tins with “BEST BEORE OCT 07 2020”. Customer must ship remaining affected product back to the firm or destroy it with permission from AWERS, Inc. for a full refund.
    AWERS, Inc. can be reached by phone at (425) 747-7866, Monday-Friday, 8 am – 6 pm PST, or by email at awersinc1@gmail.com.
  • Tyson Foods Inc., a Pine Bluff, Ark. establishment, is recalling approximately 39,078 pounds of Weaver brand frozen chicken patty product that may be contaminated with extraneous materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, fully cooked chicken items were produced on January 31, 2019. The following products are subject to recall:[View labels (PDF only)]
    26-oz. resealable plastic bags containing “Weaver CHICKEN BREAST PATTIES BREADED CHICKEN BREAST PATTIES WITH RIB MEAT” with a best if used by date of “Jan312020” and lot code 0319PBF0617, 0319PBF0618, 0319PBF0619, 0319PBF0620, 0319PBF0621, 0319PBF0622, 0319PBF0623, or 0319PBF0600 represented on the label.
    The products subject to recall bear establishment number “P-13456” printed on the back of the resealable plastic bag. These items were shipped to retail locations nationwide.Members of the media with questions about the recall can contact Morgan Watchous, Communications Manager, Tyson Foods Inc., at (479) 290-5394. Consumers with questions about the recall can call or text Tyson Foods’ Consumer Relations hotline at (855) 382-3101.
  • Pfizer Inc. is voluntarily recalling RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. initiated this recall because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.
    Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections. In addition, there is risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease) there may be the potential for serious adverse events including life- threatening infections. To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.
    RELPAX®(eletriptan hydrobromide) is indicated for the acute treatment of migraine with or without aura in adults.
    RELPAX ® (eletriptan hydrobromide) 40 mg tablets are packaged in cartons as indicated below. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019, to July 2019.
    Carton NDC
    Lot
    Number
    Expiration
    Date
    Strength
    Configuration/Count
    0049-2340-45
    AR5407
    2022 FEB
    40 mg
    Carton containing 6 tablets (1 blister card x 6 tablets)
    0049-2340-05
    CD4565
    2022 FEB
    40 mg
    Carton containing 12 tablets (2 blister cards x 6 tablets)
    Pfizer Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer Inc. has notified its direct customers via a recall letter to arrange for return of any recalled product.
    Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For retailers, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, call Stericycle at 877-225-9750 (Monday through Friday, 8 a.m. to 5 p.m. ET).
    For clinical inquiries, please contact Pfizer using the below information.Contact Center
    Contact Information
    Area of Support
    Pfizer Medical Information
    800-438-1985, option 3
    (Monday through Friday 9am to 5pm ET)
    For medical questions regarding this product
    Pfizer Drug Safety
    800-438-1985, option 1 (24 hours a day 7 days per week)
    To report adverse events or product complaints
    Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the
    affected product lots. Patients with the affected lots should return the product to their pharmacy or contact Stericycle Inc. at 877-225-9750 for instructions on how to return their product and obtain reimbursement for their cost.
    If you have received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check if you have received any of the affected product lots above. If you have any of the affected product lots in your possession, please contact your healthcare provider to return the product to them.
    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • update• 077-2019, CM&R Inc. Recalls Beef Stick Products due to Misbranding and Undeclared Allergens (Jul 24, 2019)
  • update* 082-2019 Top Taste Food Warehouse Recalls Meat and Poultry Products Produced Without Benefit of Inspection | En Español
  • Comtan, Stalevo (entacapone): Drug Safety Communication – Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and Possible Development of Prostate Cancer
    [Posted 08/13/2019]FDA alerted the public of a clinical trial in March 2010 suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. FDA subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. FDA also studied this issue independently using data from the Department of Veterans Affairs Health Care System. Based on these additional studies, FDA concluded that entacapone use is not associated with an increased risk of prostate cancer ( see Data Summary).As a result, FDA’ s recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.Health care professionals should follow standard prostate cancer screening recommendations for patients.Patients should continue to take their medicine as prescribed. Talk to your health care professionals if you have any questions or concerns.Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Miracle Mineral Solution (MMS): FDA warns consumers about the dangerous and potentially life threating side effects! FDA is warning consumers not to purchase or drink the product sold online as a medical treatment due to a recent rise in reported health issues. The solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects.  Five plastic bottles labeled with "Miracle Mineral Solution" and similar product names followed by an equal sign and a bottle labeled "Chlorine Dioxide - Powerful Bleaching Agent"

The FDA recently received new reports of people experiencing severe vomiting, severe diarrhea, life-threatening low blood pressure caused by dehydration and acute liver failure after drinking these products. The FDA is not aware of any scientific evidence supporting the safety or effectiveness of MMS products, despite claims that the solution is an antimicrobial, antiviral and antibacterial.

BACKGROUND: Since 2010, the FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, Water Purification Solution and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions.

RECOMMENDATION: The FDA encourages consumers to talk to a health care professional about treating medical conditions or diseases. Consumers who have experienced an adverse health effect after ingesting this product should seek immediate medical attention.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report online.

  • Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of baby spinach. The products being recalled are 6 oz Dole Baby Spinach bag, Lot code W20308A (UPC code 0-71430-00964-2), and 10 oz Dole Baby Spinach clamshell, Lot code W203010 (UPC code 0-71430-00016-8), both with Use-by dates of 08-05-2019, due to a possible health risk from Salmonella. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported in association with the Recall.
    The lot code and Use-by date are located on the upper right corner of the bag or on the top label of the clamshell; the UPC code is located on the bottom left corner of the back of the bag or on the bottom label of the clamshell. The impacted products were distributed in IL, IN, KY, MI, NJ, NY, OH, TN, VA, and WI. This product is expired and should no longer be on retail shelves. Consumers are advised to check product they have in their homes and discard any product matching these lot and UPC codes and Use-by dates.
    This precautionary Recall notification is being issued due to a sample of Baby Spinach which yielded a positive result for Salmonella in a random sample test conducted by the Department of Agriculture in Michigan.
    Salmonella is an organism that can cause foodborne illness in a person who eats a food item contaminated with it.
    Symptoms of infection may include fever, diarrhea, nausea, vomiting and abdominal pain. The illness primarily impacts young children, frail or elderly people, and others with weakened immune systems. Most healthy adults and children rarely become seriously ill after exposure to Salmonella.
    No other Dole products are included in the recall. Only the specific Baby Spinach products listed, with the exact Lot codes, UPC codes and Use-by dates identified above, are included in the recall. Consumers who have any remaining product with these Lot codes, UPC codes and Use-by dates should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center at 1-800-356-3111, which is open 24 hours a day.
  • Taylor Farms Inc., a Chicago, Ill. establishment, is recalling approximately 342 pounds of breaded chicken products due to a processing defect that may have led to undercooking of products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ready-to-eat breaded chicken items were produced August 3, 2019. The following products are subject to recall: [View labels (PDF only)]
    14.75-oz. sealed clear trays containing “Parmesan Topped Chicken with Spaghetti” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/14/19 and 8/15/19 represented on the label.
    12.5-oz. sealed clear trays containing “Homestyle Fried Chicken Dinner” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/13/19 and 8/14/19 represented on the label.
    9-oz. cardboard trays with plastic lids containing “Breaded Chicken Breast” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/09/19 and 8/10/19 represented on the label.
    The products subject to recall bear establishment number “EST. or P-21794” inside the USDA mark of inspection. These items were shipped to retail locations in Arkansas, Michigan, Mississippi, Ohio, Tennessee, and West Virginia where the products are sold in the deli section of retailers.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    Members of the media with questions about the recall can contact the Taylor Farms’ press team at press@taylorfarms.com. Consumers with questions about the recall can the Taylor Farms’ Customer Hotline at 855-455-0098.
  • MedWatch –
    TOPIC: PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products by Ridge Properties LLC DBA Pain Relief Naturally: Recall – Due to Microbiological Contamination and Superpotency
    ISSUE: Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine.  

    The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application and tattooing is known to have infectious complications. Additionally, use of lidocaine greater than the label claim may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced. To date, the company has not received any reports of adverse events related to this recall.
    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
    • Complete and submit the report online.
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

     

  • Top Taste Food Warehouse, a Brooklyn, N.Y. establishment, is recalling an undetermined amount of pork and chicken dumpling product because they were produced, packed, and distributed without the benefit of USDA inspection and used the mark of inspection without authorization, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen pork with vegetable dumpling and the chicken with vegetable dumpling items were produced July 30, 2018 through July 31, 2019. The following products are subject to recall: [View labels (PDF only)]
    136-oz (8.5-lbs) plastic bags containing approximately 100 pieces of “TOP TASTE PORK & VEGETABLE DUMPLINGS.”
    136-oz (8.5-lbs) plastic bags containing approximately 100 pieces of “TOP TASTE CHICKEN & VEGETABLE DUMPLINGS.”
    The products subject to recall bear establishment number “EST. 19856” inside the USDA mark of inspection.These items were shipped to wholesalers in New York.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Wan Tung Tong, Vice President of Top Taste Food Inc., at (917) 604- 6950.
  • update• 064-2019, Perdue Foods LLC Recalls Perdue Simply Smart Organics Poultry Products Due to Possible Foreign Matter Contamination (May 31, 2019)

A MedWatch Safety Alert was just added to the FDA Medical Device Recalls webpage.  Ellipse Implantable Cardioverter Defibrillators by Abbott (Formerly St. Jude Medical Inc.): Class I Recall – Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

ISSUE: A88bbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed.

None of the complainst or Medical Device Reporting reports (MDRs) indicate that any patient harm or adverse events have occurred and no deaths have been reported.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
Read Recall

  • Bimbo Bakeries USA, Inc. has initiated a voluntary recall of Entenmann’s Little Bites Soft Baked Cookies (5 pack Mini Chocolate Chip variety) due to the potential presence of visible, blue plastic pieces in the individual packaging pouch. The plastic is not baked into the product since it was introduced during the packaging process; however, consumption of the plastic pieces may result in a choking hazard. Entenmann’s Little Bites Cookies are made on a dedicated production line, so no Little Bites Muffins or other Entenmann’s brand products are affected.

The product being recalled has “Best By” date, UPC and Lot code and was distributed in the states listed below. The Best By Date can be found on the top of the box, the Lot Code is to the left of the top of the box underneath the price/lb. The UPC Code can be found in the lower right hand corner on the back of the box.
Product Name/Description
Best By Dates
UPC Code
Lot Code
States
Entenmann’s Little Bites Soft Baked Chocolate Chip Cookies (5pk)
August 31, 2019 & September 7, 2019
7203002378
1350
AL, AR, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, SD, TN, VA, VT, WI, WV
The company announced the recall after receiving consumer reports of visible, blue plastic pieces found on or packaged with the product. There are no reports of injury to date. The Food and Drug Administration (FDA) has been notified of this voluntary recall.
All recalled products are being removed from store shelves. No Entenmann’s Little Bites Muffins nor other Entenmann’s products are affected.
Consumers who have purchased the cookies should not consume the product and can return the package to its place of purchase for a full refund. Consumers with questions may contact our Consumer Relations group at 1- 800-984-0989 24 hours a day, seven days a week.

 

 

 

 

 

 

 

 


  • Mountain Mel’s Essential Goods, LLC of Welches, OR
    is recalling The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and Diges-Teas Herbal Tea with LOT # DT7619100, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The Milk Lady’s, Peaceful Baby, and Diges-Teas were distributed in Oregon and Washington through New Seasons Market, and nationwide through Azure Standard, Mountainmels.com and Amazon.com. The affected tea products were distributed by Mountain Mel’s Essential Goods June 27, 2019 and July 20, 2019.The Milk Lady’s Herbal Tea Blend, UPC 7 99632 05658 4, is packaged in a tall thin tin container with 2 oz of tea per tin, with a purple label. The LOT# of the recalled batch is # ML6271950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Milk Lady’s Tea is listed as 7/2021.Peaceful Baby Herbal Tea Blend, UPC 7 99632 05656 0, is packaged in a tall thin tin container with 2 oz of tea per tin, with a blue label. The LOT# of the recalled batch is #PB781950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Peaceful Baby Tea is listed as 7/2021.Diges-Teas Herbal Tea Blend, UPC 7 99632 05665 2, is packaged in a tall thin tin container with 2 oz of tea per tin, with a brown label. The LOT# of the recalled batch is #DT7619100. The LOT# can be located on the bottom of the tin package. The Best By Date of the Diges-Teas Herbal Tea is listed as 7/2021.No illnesses have been reported to date.

    This recall was initiated because the herbal teas were made with the recalled fennel seed whole that was supplied and recalled by Mountain Rose Herbs in Oregon. Mountain Mel’s Essential Goods has ceased production and distribution of this product as of July 20, 2019.

    This recall is being made with the knowledge of the U.S. Food and Drug Administration.

    Consumers who have purchased Mountain Mel’s The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and/or Diges-Teas Herbal Tea with LOT # DT7619100 are urged to take a photo of the product and lot label, email that to info@mountainmels.com for a full refund.

  • Heatherfield Foods, Inc., an Ontario, Calif. establishment, is recalling approximately 4,380 pounds of pork sausage products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product has a gluten free claim represented on the front of the label; however, the product contains gluten in the form of wheat. Wheat, which is an allergen, is also listed in the product’s list of ingredients.

    The raw Longanisa sausage items were produced on various dates between March 8, 2019 and July 31, 2019. The following product is subject to recall: [View labels (PDF only)]

    • 1-lb. thermoform tray packages containing “HAWAIIAN SAUSAGE COMPANY Sweet Filipino Longanisa ˙NO PRESERVATIVES ˙GLUTEN FREE ˙NO MSG” with lot codes 09067, 09081, 09088, 09113, 09130, 09148, 09156, 09163, 09170, 09179, 09193 and 09212 on the label.

    The products subject to recall bear establishment number “EST. 4846” inside the USDA mark of inspection. These items were shipped to retail locations in Hawaii.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  Consumers and members of the media with questions about the recall can contact John Brown, Vice President, Heatherfield Foods Inc., at (909) 460-4150.

  • American Beef Packers, Inc., a Chino, Calif. establishment, is recalling approximately 24,428 pounds of raw beef products that are deemed unfit for human consumption, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

    FSIS inspection personnel retained the carcass and collected a sample for further analysis. Prior to test results being received, the carcass was erroneously released and further processed into raw intact and non-intact beef products, which were distributed in commerce.

    The raw beef items were produced and packaged on Aug. 21, 2019.

    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 85 BONELESS BEEF CHUCKS” with LOT NO.110 and BIN No. 85 and BIN No. 86.
    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 90 BONELESS BEEF” with LOT NO. 110 and BIN No. 81, BIN No. 82 and BIN No. 83.
    • Bulk pack combo bins containing “AMERICAN BEEF PACKERS 85 BONELESS BEEF” with LOT NO. 25-110 and BIN No. 84 and LOT NO 110 and BIN No. 88.
    • Cases containing “AMERICAN BEEF PACKERS RIBEYE 8/10 #1” with codes BT190821-1178, BT190821-1185, BT190821-1188, BT190821-1190, and BT190821-1194.
    • 66.2-lb. case containing “AMERICAN BEEF PACKERS RIBEYE 10 UP #1” with code BT190821-1186.
    • Bulk pack combo bin containing “AMERICAN BEEF PACKERS 90 BONELESS BEEF SIRLOINS” with LOT NO. 24-110 and BIN No. 80.
    • Cases containing “AMERICAN BEEF PACKERS TERDERLOIN 4 UP” with codes BT190821-1160, BT190821-1161, BT190821-1162, BT190821-1163, BT190821-1167, BT190821-1168, BT190821-1169, and BT190821-1170.
    • Cases containing “AMERICAN BEEF PACKERS RIBEYE 10 UP” with codes BT190821-1187 and BT190821-1192.
    • Cases containing “AMERICAN BEEF PACKERS TENDERLOIN 3/4” with codes BT190821-1155, BT190821-1157, BT190821-1171, BT190821-1200, BT190821-1201, BT190821-1202, BT190821-1203, BT190821-1204, and BT190821-1205.
    • 50-lb. cases containing “AMERICAN BEEF PACKERS DESC: BEEF FOR FURTHER PROCESSING 75/25” with lot code 08347412719.

    The products subject to recall bear establishment number “EST. 34741” inside the USDA mark of inspection. These items were shipped to federal establishments in California and Oregon.

    The firm notified FSIS on Aug. 30, 2019 that a carcass that was pending laboratory results had been erroneously released and further processed into raw intact and non-intact beef products.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

 

Hepatitis C Medicines [Mavyret (glecaprevir and pibrentasvir), Zepatier (elbasvir and grazoprevir), and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)]: Drug Safety Communication – Rare Occurrence of Serious Liver Injury in Some Patients with Advanced Liver Disease

AUDIENCE: Gastroenterology, Infectious Disease, Health Professional, Patient, Pharmacy

ISSUE: FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat

chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

FDA identified 63 cases of worsening liver function called liver decompensation with regimens Mavyret, Zepatier, and Vosevi to treat Hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.

RECOMMENDATION: Health professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A).

Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation. Vosevi is indicated for patients who have previously failed certain other Hepatitis C Virus treatments and is not recommended in patients with any history of hepatic decompensation unless the benefits outweigh the risk of liver injury, liver failure or death.

Patients should be aware that the risk of serious liver injury is rare. However, patients should contact a health professional right away if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

  • Update * Bakkavor Foods USA, Inc., a San Antonio, Texas establishment, is recalling approximately 1,913 pounds of ready-to-eat (RTE) chicken salad products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains pecans (tree nut), a known allergen, which is not declared on the product label.

    The RTE chicken salad products are labeled as “Curry Chicken Salad” products but contain Tarragon Chicken Salad products.  The items were produced on August 20, 2019.

    The following products are subject to recall [View Labels (PDF only)]:

    • 12 oz.  clear plastic squared containers of “SIMPLY EAT HEB MEAL SIMPLE CURRY CHICKEN SALAD” with a best by date of 08/28/2019.

    The products subject to recall bear establishment number “P-46445” inside the USDA mark of inspection. These items were shipped to a chain of retail grocery locations in Texas.

    The problem was discovered by the company during a review of production records.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

  • Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Veterinary ophthalmic drug products and lots, within expiry, identified below. This recall is only for the specific lots listed. No other lots are being recalled.Altaire is initiating the recall due to concerns regarding some QA controls in the manufacturing facility. The recalled products will be evaluated as part of Altaire’s review. As of this date, Altaire is pleased to state that they have not received any reports of adverse events from the use of the recalled products and lot #’s.Product Description: Vetropolycin Ophthalmic Ointment NDC Number: 17033-028-38  Package Size: 3.5 gm  Lot #:/ Exp. Date: 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ  (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (01/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ  (01/2), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21).Product Description: Vetropolycin HC Ophthalmic Ointment NDC Number: 17033-030-88 Package Size: 3.5 gm Lot #:/ Exp. Date: 17243/RHF (08/19), 17324/RJQ (10/19), 17326/RKA (11/19), 17327/RKB (11/19), 17328/RKC (11/19), 17389/RLN (12/19), 18013/SAH (01/20), 18028/SAQ (01/20), 18039/SBD (02/20), 19118/TDK (04/21).Product Description: Puralube Vet Ophthalmic Ointment NDC Number:  17033-211-38  Package Size: 3.5 gm Lot #:/ Exp. Date: 17246/RHH (08/19), 17265/RHQ (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19), 17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (018/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ (01/21), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21)The products are manufactured and labeled exclusively for Dechra Veterinary Products. Altaire ships the products only to Dechra Veterinary Products. The products are distributed by Dechra Veterinary Products.Altaire has notified Dechra by e-mail on August 22, 2019 announcing the recalls of the products/lots identified herein, with specific directions to recall all units of the impacted lots. Altaire has also asked  Dechra to notify their downstream supply chain partners of the recall, and perform a sub-recall to the retail level.Dechra customers with questions regarding this recall can contact Dechra directly by calling 1-866-933-2472, or e-mailing support@dechra.com. Pet Owners should contact their veterinary care provider if they have any questions.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Center for Veterinary Medicine (CVM) program by using FORM FDA 1932a “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report” as follows:
    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

  • Olympia Meats, a Portland, Ore., establishment is recalling approximately 198 pounds of ready-to-eat (RTE) pork sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains pistachios (tree nuts), a known allergen, which is not declared on the product label.

    The RTE pork sausage products are labeled as “Mortadella Classica” products but contain Mortadella Pistachio sausage products. The items were produced on July 29, 2019.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  Consumers with questions about the recall can contact Alexis Heimlich, at (503) 894-8275 or alexis@olympiaprovisions.com. Members of the media with questions about the recall can contact Megan Moran, at (503) 894-8275 or megan@olympianprovisions.com.

    The products subject to recall bear establishment number “Est. 39928” inside the USDA mark of inspection. These items were shipped to retail locations in California, Oregon, and Washington.            Varying weights of vacuum packed “OLYMPIA PROVISIONS MORTADELLA CLASSICA WITH GARLIC AND SPICES” with a best by date of l2-30-2019.

  • Tip Top Poultry, Inc., a Rockmart, Ga. establishment, is recalling approximately 135,810 pounds of fully cooked poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, diced, and mechanically separated ready to eat chicken was produced on January 21, 2019 and display “PACK DATE 01/21/19” on the labels. The products subject to recall can be found in this spreadsheet. [View labels (PDF only)]
The products subject to recall bear establishment number “P-17453” inside the USDA mark of inspection or on the case. These items were shipped to hotels, restaurants, and institutions nationwide.
The problem was discovered on August 17, 2019, when the Canadian Food Inspection Agency (CFIA) notified FSIS that a sample of product produced by Tip Top Poultry, Inc. confirmed positive for the presence of Listeria monocytogenes.
Canadian public health and food safety partners, including the Public Health Agency of Canada and the Canadian Food Inspection Agency, have been investigating an outbreak of Listeria monocytogenes. A ready-to-eat diced chicken product collected as part of the investigation tested positive for Listeria monocytogenes. The investigation is ongoing.Media and consumers with questions regarding the recall can contact Terry Bruce, Senior V.P., Operational Quality, Tip Top Poultry, at (770) 973-8070.

  • AWERS, Inc. of Bellevue, WA is recalling Grained Salmon Caviar 95g (Sockeye Salmon Caviar) with “BEST BEFORE OCT 07 2020”, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
    Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
    Grained Salmon Caviar 95g was distributed in California, New York, Oregon, Washington and product may have further distributed to other states and Canada.
    Product is packed in a metal tin with Cyrillic lettering. The tin is green, with red and white writing with an easy open pull lid. The “BEST BEFORE OCT 07 2020” is printed on the bottom on the tin (See attached photo).
    No illnesses have been reported to date.
    The product was reviewed by the Canadian Food Inspection Agency (CFIA) and sent to a lab for testing. The analysis showed a lower than normal salt content, which can foster an anaerobic environment which is necessary to breed the Clostridium botulinum bacteria. No Clostridium botulinum bacteria was detected in product.
    This recall is being made with the knowledge of the U.S. Food and Drug Administration.
    Consumers must inform AWERS, Inc. if they possess any Grained Salmon Caviar 95g tins with “BEST BEORE OCT 07 2020”. Customer must ship remaining affected product back to the firm or destroy it with permission from AWERS, Inc. for a full refund.
    AWERS, Inc. can be reached by phone at (425) 747-7866, Monday-Friday, 8 am – 6 pm PST, or by email at awersinc1@gmail.com.
  • Tyson Foods Inc., a Pine Bluff, Ark. establishment, is recalling approximately 39,078 pounds of Weaver brand frozen chicken patty product that may be contaminated with extraneous materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, fully cooked chicken items were produced on January 31, 2019. The following products are subject to recall:[View labels (PDF only)]
    26-oz. resealable plastic bags containing “Weaver CHICKEN BREAST PATTIES BREADED CHICKEN BREAST PATTIES WITH RIB MEAT” with a best if used by date of “Jan312020” and lot code 0319PBF0617, 0319PBF0618, 0319PBF0619, 0319PBF0620, 0319PBF0621, 0319PBF0622, 0319PBF0623, or 0319PBF0600 represented on the label.
    The products subject to recall bear establishment number “P-13456” printed on the back of the resealable plastic bag. These items were shipped to retail locations nationwide.Members of the media with questions about the recall can contact Morgan Watchous, Communications Manager, Tyson Foods Inc., at (479) 290-5394. Consumers with questions about the recall can call or text Tyson Foods’ Consumer Relations hotline at (855) 382-3101.
  • Pfizer Inc. is voluntarily recalling RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. initiated this recall because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.
    Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections. In addition, there is risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease) there may be the potential for serious adverse events including life- threatening infections. To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.
    RELPAX®(eletriptan hydrobromide) is indicated for the acute treatment of migraine with or without aura in adults.
    RELPAX ® (eletriptan hydrobromide) 40 mg tablets are packaged in cartons as indicated below. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019, to July 2019.
    Carton NDC
    Lot
    Number
    Expiration
    Date
    Strength
    Configuration/Count
    0049-2340-45
    AR5407
    2022 FEB
    40 mg
    Carton containing 6 tablets (1 blister card x 6 tablets)
    0049-2340-05
    CD4565
    2022 FEB
    40 mg
    Carton containing 12 tablets (2 blister cards x 6 tablets)
    Pfizer Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer Inc. has notified its direct customers via a recall letter to arrange for return of any recalled product.
    Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For retailers, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, call Stericycle at 877-225-9750 (Monday through Friday, 8 a.m. to 5 p.m. ET).
    For clinical inquiries, please contact Pfizer using the below information.Contact Center
    Contact Information
    Area of Support
    Pfizer Medical Information
    800-438-1985, option 3
    (Monday through Friday 9am to 5pm ET)
    For medical questions regarding this product
    Pfizer Drug Safety
    800-438-1985, option 1 (24 hours a day 7 days per week)
    To report adverse events or product complaints
    Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the
    affected product lots. Patients with the affected lots should return the product to their pharmacy or contact Stericycle Inc. at 877-225-9750 for instructions on how to return their product and obtain reimbursement for their cost.
    If you have received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check if you have received any of the affected product lots above. If you have any of the affected product lots in your possession, please contact your healthcare provider to return the product to them.
    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • update• 077-2019, CM&R Inc. Recalls Beef Stick Products due to Misbranding and Undeclared Allergens (Jul 24, 2019)
  • update* 082-2019 Top Taste Food Warehouse Recalls Meat and Poultry Products Produced Without Benefit of Inspection | En Español
  • Comtan, Stalevo (entacapone): Drug Safety Communication – Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and Possible Development of Prostate Cancer
    [Posted 08/13/2019]FDA alerted the public of a clinical trial in March 2010 suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. FDA subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. FDA also studied this issue independently using data from the Department of Veterans Affairs Health Care System. Based on these additional studies, FDA concluded that entacapone use is not associated with an increased risk of prostate cancer ( see Data Summary).As a result, FDA’ s recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.Health care professionals should follow standard prostate cancer screening recommendations for patients.Patients should continue to take their medicine as prescribed. Talk to your health care professionals if you have any questions or concerns.Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Miracle Mineral Solution (MMS): FDA warns consumers about the dangerous and potentially life threating side effects! FDA is warning consumers not to purchase or drink the product sold online as a medical treatment due to a recent rise in reported health issues. The solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects.  Five plastic bottles labeled with "Miracle Mineral Solution" and similar product names followed by an equal sign and a bottle labeled "Chlorine Dioxide - Powerful Bleaching Agent"

The FDA recently received new reports of people experiencing severe vomiting, severe diarrhea, life-threatening low blood pressure caused by dehydration and acute liver failure after drinking these products. The FDA is not aware of any scientific evidence supporting the safety or effectiveness of MMS products, despite claims that the solution is an antimicrobial, antiviral and antibacterial.

BACKGROUND: Since 2010, the FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, Water Purification Solution and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions.

RECOMMENDATION: The FDA encourages consumers to talk to a health care professional about treating medical conditions or diseases. Consumers who have experienced an adverse health effect after ingesting this product should seek immediate medical attention.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report online.

  • Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of baby spinach. The products being recalled are 6 oz Dole Baby Spinach bag, Lot code W20308A (UPC code 0-71430-00964-2), and 10 oz Dole Baby Spinach clamshell, Lot code W203010 (UPC code 0-71430-00016-8), both with Use-by dates of 08-05-2019, due to a possible health risk from Salmonella. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported in association with the Recall.
    The lot code and Use-by date are located on the upper right corner of the bag or on the top label of the clamshell; the UPC code is located on the bottom left corner of the back of the bag or on the bottom label of the clamshell. The impacted products were distributed in IL, IN, KY, MI, NJ, NY, OH, TN, VA, and WI. This product is expired and should no longer be on retail shelves. Consumers are advised to check product they have in their homes and discard any product matching these lot and UPC codes and Use-by dates.
    This precautionary Recall notification is being issued due to a sample of Baby Spinach which yielded a positive result for Salmonella in a random sample test conducted by the Department of Agriculture in Michigan.
    Salmonella is an organism that can cause foodborne illness in a person who eats a food item contaminated with it.
    Symptoms of infection may include fever, diarrhea, nausea, vomiting and abdominal pain. The illness primarily impacts young children, frail or elderly people, and others with weakened immune systems. Most healthy adults and children rarely become seriously ill after exposure to Salmonella.
    No other Dole products are included in the recall. Only the specific Baby Spinach products listed, with the exact Lot codes, UPC codes and Use-by dates identified above, are included in the recall. Consumers who have any remaining product with these Lot codes, UPC codes and Use-by dates should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center at 1-800-356-3111, which is open 24 hours a day.
  • Taylor Farms Inc., a Chicago, Ill. establishment, is recalling approximately 342 pounds of breaded chicken products due to a processing defect that may have led to undercooking of products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ready-to-eat breaded chicken items were produced August 3, 2019. The following products are subject to recall: [View labels (PDF only)]
    14.75-oz. sealed clear trays containing “Parmesan Topped Chicken with Spaghetti” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/14/19 and 8/15/19 represented on the label.
    12.5-oz. sealed clear trays containing “Homestyle Fried Chicken Dinner” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/13/19 and 8/14/19 represented on the label.
    9-oz. cardboard trays with plastic lids containing “Breaded Chicken Breast” with lot codes TFIL215A001 and TFIL216A001 and “Use by” dates 8/09/19 and 8/10/19 represented on the label.
    The products subject to recall bear establishment number “EST. or P-21794” inside the USDA mark of inspection. These items were shipped to retail locations in Arkansas, Michigan, Mississippi, Ohio, Tennessee, and West Virginia where the products are sold in the deli section of retailers.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    Members of the media with questions about the recall can contact the Taylor Farms’ press team at press@taylorfarms.com. Consumers with questions about the recall can the Taylor Farms’ Customer Hotline at 855-455-0098.
  • MedWatch –
    TOPIC: PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products by Ridge Properties LLC DBA Pain Relief Naturally: Recall – Due to Microbiological Contamination and Superpotency
    ISSUE: Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine.  

    The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application and tattooing is known to have infectious complications. Additionally, use of lidocaine greater than the label claim may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced. To date, the company has not received any reports of adverse events related to this recall.
    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
    • Complete and submit the report online.
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

     

  • Top Taste Food Warehouse, a Brooklyn, N.Y. establishment, is recalling an undetermined amount of pork and chicken dumpling product because they were produced, packed, and distributed without the benefit of USDA inspection and used the mark of inspection without authorization, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen pork with vegetable dumpling and the chicken with vegetable dumpling items were produced July 30, 2018 through July 31, 2019. The following products are subject to recall: [View labels (PDF only)]
    136-oz (8.5-lbs) plastic bags containing approximately 100 pieces of “TOP TASTE PORK & VEGETABLE DUMPLINGS.”
    136-oz (8.5-lbs) plastic bags containing approximately 100 pieces of “TOP TASTE CHICKEN & VEGETABLE DUMPLINGS.”
    The products subject to recall bear establishment number “EST. 19856” inside the USDA mark of inspection.These items were shipped to wholesalers in New York.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Wan Tung Tong, Vice President of Top Taste Food Inc., at (917) 604- 6950.
  • update• 064-2019, Perdue Foods LLC Recalls Perdue Simply Smart Organics Poultry Products Due to Possible Foreign Matter Contamination (May 31, 2019)

A MedWatch Safety Alert was just added to the FDA Medical Device Recalls webpage.  Ellipse Implantable Cardioverter Defibrillators by Abbott (Formerly St. Jude Medical Inc.): Class I Recall – Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

ISSUE: A88bbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed.

None of the complainst or Medical Device Reporting reports (MDRs) indicate that any patient harm or adverse events have occurred and no deaths have been reported.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
Read Recall

  • Bimbo Bakeries USA, Inc. has initiated a voluntary recall of Entenmann’s Little Bites Soft Baked Cookies (5 pack Mini Chocolate Chip variety) due to the potential presence of visible, blue plastic pieces in the individual packaging pouch. The plastic is not baked into the product since it was introduced during the packaging process; however, consumption of the plastic pieces may result in a choking hazard. Entenmann’s Little Bites Cookies are made on a dedicated production line, so no Little Bites Muffins or other Entenmann’s brand products are affected.

The product being recalled has “Best By” date, UPC and Lot code and was distributed in the states listed below. The Best By Date can be found on the top of the box, the Lot Code is to the left of the top of the box underneath the price/lb. The UPC Code can be found in the lower right hand corner on the back of the box.
Product Name/Description
Best By Dates
UPC Code
Lot Code
States
Entenmann’s Little Bites Soft Baked Chocolate Chip Cookies (5pk)
August 31, 2019 & September 7, 2019
7203002378
1350
AL, AR, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, SD, TN, VA, VT, WI, WV
The company announced the recall after receiving consumer reports of visible, blue plastic pieces found on or packaged with the product. There are no reports of injury to date. The Food and Drug Administration (FDA) has been notified of this voluntary recall.
All recalled products are being removed from store shelves. No Entenmann’s Little Bites Muffins nor other Entenmann’s products are affected.
Consumers who have purchased the cookies should not consume the product and can return the package to its place of purchase for a full refund. Consumers with questions may contact our Consumer Relations group at 1- 800-984-0989 24 hours a day, seven days a week.

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