FDA/USDA ~ December ~ Alerts & Safety ~ 2019


  • Sprouts Unlimited of Marion IA is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria (E. coli O103). E. coli O103 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
    The affected batches of clover sprouts were distributed to Hy Vee Food stores, Fareway Food Stores and Jimmy John’s restaurants in Iowa.
    The sprouts available at retail were packaged in in pint containers from Sprouts Unlimited Inc. with a blue label on the lid. The UPC code 7 32684 00013 6 is stamped on the bottom right side of the label.
    Sprouts Unlimited Inc. became aware of the potential contamination after receiving information from the Iowa Department of Inspections and Appeals, Des Moines, IA that a cluster of E. coli O103 illnesses epidemiologically linked to clover sprouts from Sprouts Unlimited Inc. An investigation and further tests are being conducted to determine the source.
    If consumers have affected product in their home, they should discontinue use of the product immediately and return any product to the retail store for a full refund. If you have any questions, please call Bill Beach at Sprouts Unlimited Inc. at 319-360-4586.
  • Bakkavor Foods USA, Inc. is voluntarily recalling Trader Joe’s Egg Salad, 6 oz and Trader Joe’s Old Fashioned Potato Salad, 20 oz with “USE BY” date codes up through and including 12/27/19 because these products have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
    This recall is taking place due notification by Almark Foods of Gainesville, GA that they supplied certain lots of Broken Egg Whites products in 20 Lbs pails which may be contaminated with Listeria monocytogenes and its association with a Listeria monocytogenes foodborne illness investigation.
    Products were distributed to Trader Joe’s retail stores in Alabama, Connecticut, DC, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Vermont and Wisconsin.
    The products come in plastic cups and trays with SKU numbers printed on the labels and “USE BY” date codes applied to top or bottom of the containers.
    Product
    Code Date
    Trader Joe’s Egg Salad 6 oz Cups
    UPC 0066 6695
    “USE BY “dates up through and including “12/27/19”
    Trader Joe’s Old Fashioned Potato Salad, 20 oz Trays
    UPC 0032 1747
    “USE BY “dates up through and including “12/27/19”
    To date there have been no confirmed illnesses.
    Consumers should discard the product immediately or return it to their point of purchase for a full refund. Customers with questions may contact Bakkavor Foods at (855) 312-7504, Monday through Friday 8:00P.M. – 5:00P.M. PST.
  • Due to a recent recall by Almark, an ingredient supplier, and out of an abundance of caution for safety of our customers St. Louis based Dierbergs Markets is recalling various products in all 25 retail stores. The hardboiled egg products have the potential to be contaminated with Listeria monocytogenes. Almark’s product is associated with an outbreak of Listeriosis illness consisting of 7 known illnesses in 5 states. No illnesses are linked to Dierberg products to date, but the epidemiological investigation is ongoing. The products are being recalled as a precautionary measure given the health and safety of our consumers is our top priority.
    All of the implicated products have been removed from store shelves. Product was distributed to all Dierbergs Markets retail locations in eastern and central Missouri and western Illinois.
    Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.Item Being Recalled Description
    Size
    UPC
    Use by Dates
    Dierbergs Kitchen Kosher Potato Salad
    12OZ
    23753400000
    1/12/20 and earlier
    Dierbergs Kitchen Kosher Potato Salad
    2LB
    23117500000
    1/12/20 and earlier
    Dierbergs Kitchen Kosher Potato Salad
    Bulk by pound, Party Orders, Service Case
    23494500000
    1/12/20 and earlier
    Dierbergs Kitchen Creamy Red Potato Salad
    12OZ
    23116800000
    1/12/20 and earlier
    Dierbergs Kitchen Creamy Red Potato Salad
    2LB
    23117000000
    1/12/20 and earlier
    Dierbergs Kitchen Creamy Red Potato Salad
    Bulk by pound, Party Orders, Service Case
    23492000000
    1/12/20 and earlier
    Dierbergs Kitchen Deviled Egg Salad
    12 OZ
    23282100000
    1/1/20 and earlier
    Dierbergs Kitchen Deviled Egg Salad
    By Pound Service Case, Party Sandwiches
    23397300000
    1/1/20 and earlier
    Dierbergs Kitchen Remoulade
    12oz Container
    2393330149
    1/05/20 and earlier
    Dierbergs Kitchen Remoulade
    12oz Container
    24616200000
    1/05/20 and earlier
    Dierbergs Kitchen Remoulade
    Bulk By Pound, Service Case
    24696500000
    1/05/20 and earlier
    Dierbergs Kitchen Salad Togo Grilled Chicken Cobb Salad
    Large
    2393393222
    12/26/19 and earlier
    Dierbergs Kitchen Salad Togo Grilled Chicken Cobb Salad
    Small
    2393393192
    12/26/19 and earlier
    Dierbergs Kitchen Salad Togo Classic Ham & Turkey Chef Salad
    Large
    2393393217
    12/26/19 and earlier
    Dierbergs Kitchen Salad Togo Classic Ham & Turkey Chef Salad
    Small
    2393393216
    12/26/19 and earlier
    Dierbergs Markets is working closely with the Food & Drug Administration. No other Dierbergs Branded products are affected by this recall.
    Dierbergs Markets is asking consumers who have packages of the product to return them unopened to the place of purchase for a full refund. Consumers with questions may contact Dierbergs Markets at 1-636-532-8884 Monday through Friday, 8 am to 4:30 pm CDT.
  • Mavidon is notifying customers, Hospital and clinics to STOP using Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone, and all products manufactured by Mavidon IMMEDIATELY due to contamination with Burkholderia cepacia.
    Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia. We were notified on December 19, 2019 that samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection that occurred at our facility on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Out of an abundance of caution, we are recalling all products manufactured at our facility.
    Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.
    Burkholderia cepacia is a multi-drug resistant pathogenic microorganism. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals. To date, Mavidon has received one report of adverse event in a neonate related to this product in recall.
    Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single Use Cups products have uses which include as abrasive skin prepping lotions, products intended to lower skin impedance and enhance the signal quality at the electrode site, cleaning agents to remove oils and skin residue on patients with normal to oily skin . Collodions, Collodion Remover, Medical Adhesive Remover, Acetone are used to attach and remove EEG electrodes. These were distributed to hospitals, distributors, and clinics in the USA and worldwide. We are including in this worldwide recall all of our products as it is possible that contamination with B. cepacia may have taken place and gone undetected before distribution. We pledge ourselves to the highest standards of quality and out of abundance of caution we have decided to recall all products made at our facility.
    Mavidon is notifying of all of its customers by email and regular mail. Contact Mavidon at 800-654-0385 (Monday – Friday, 8:30 AM to 5:00 PM EDT) or by email to cs@mavidon.com.
  • Reichel Foods Inc. is voluntarily recalling Pro2Snax To The Max Granny Apples /Hard Boiled Egg/Cheddar/Cashew & Craisin and Pro2Snax To The Max Gala Apples/Hard Boiled Egg/White Cheddar/Almond & Craisin. These items were distributed to retailers nationwide.
    This recall is taking place due notification from Almark Foods of Gainesville, GA that Almark Foods may have supplied single serve prepackaged Hard Boiled Eggs contaminated with Listeria monocytogenes and its association with a Listeria monocytogenes foodborne illness investigation.
    Reichel Foods, Inc. has had no reported illnesses related to Pro2Snax to the Max products.
    These single serve Hard Boiled Egg products have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
    Consumers should discard the product immediately or return it to their point of purchase for a full refund. Customers with questions may contact Reichel Foods Inc. at (866) 372-2609, ext 233.
  • Great American Deli of Ooltewah, Tennessee is recalling GAD #114 Egg Salad Sandwich 4.8 oz. UPC: 7-41431-00114-2 due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, we have not received any reports of illness related to the consumption of Egg Salad Sandwiches.
    Almark Foods initiated a recall and is an ingredient supplier to one of Great American Deli’s suppliers, Knott’s Fine Foods that provides egg salad to the company.
    Affected product could have been delivered in the following states through convenience stores, micro markets and vending machines: Wisconsin, Iowa, Illinois, Missouri, Kansas, Arkansas, Louisiana, Texas, Mississippi, Alabama, Florida, Tennessee, South Carolina, North Carolina, Kentucky, Virginia, West Virginia, Ohio, Indiana, Michigan and Pennsylvania.
    Consumers who have purchased the affected sandwiches are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-343-1327 Monday – Friday 8:00 AM ET to 5:00 PM ET.
  • Ashland Sausage Co., a Carol Stream, Ill. establishment, is recalling approximately 1,092 pounds of pork sausage products that may be contaminated with extraneous materials, specifically hard, dark plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ready-to-eat (RTE) course ground sausage items were produced on Nov. 14, 2019. The following products are subject to recall: [View Labels (PDF only)]
    12-oz. plastic packages containing 5 pieces of “BERKSHIRE NATURAL CASING SAUSAGE” with lot code S318.
    The products subject to recall bear establishment number “EST. 21549” inside the USDA mark of inspection. These items were shipped to retail locations in Illinois and New York.
    FSIS was notified of the problem by the company after it received a customer complaint of finding two small pieces of dark hard plastic in the product.
    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.
    FSIS is concerned that some product may be in consumers’ freezers or refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
    Consumers and members of the media with questions about the recall can contact Paul Podgorski, plant manager, Ashland Sausage Co., at (630) 690-2600.
  • Advance Pierre Foods, a Cincinnati, Ohio establishment, is recalling approximately 15,739 pounds of ready-to-eat (RTE) beef patty products that may be contaminated with extraneous materials, specifically small, green soft plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, RTE beef patty items were produced on Sept. 11, 2019. The following products are subject to recall: [View Labels (PDF only)]
    15.09 lb. frozen, bulk-packed cases containing “CN FULLY COOKED FLAMEBROILED BEEF PATTIES” with product code 69097 on the case label.
    The products subject to recall bear establishment number “Est. 2132” inside the USDA mark of inspection. These items were shipped to a single distribution location in Iowa. The warehouse then distributed the product to institutions, including schools. While the product was distributed to schools, it resulted from a commercial sale and was not part of the food provided by the USDA for the National School Lunch Program. The product was not sold in retail stores.
    The problem was discovered after Advance Pierre Foods received a complaint from a foodservice establishment concerning green soft plastic found in a patty.
    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.
    FSIS is concerned that some product may be in institutional freezers. Institutions that have purchased these products are urged not to serve them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers.
    Consumers and members of the media with questions about the recall can contact Worth Sparkman, media relations, Tyson Foods, at (479) 290-6358.
  • Almark Foods is voluntarily recalling Hard-Boiled and Peeled Eggs in white plastic pails with white plastic lids due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
    On December 18, 2019 the firm was notified by FDA that Almark Foods’ Hard-Boiled and Peeled Eggs in pails produced at its Gainesville, Georgia facility may be associated with a Listeria monocytogenes foodborne illness investigation, which remains ongoing. Out of an abundance of caution, Almark Foods is voluntarily recalling all Hard-Cooked and Peeled Eggs in Pails produced at its Gainesville, Georgia facility that remain within expiry. The Company has suspended production of the recalled egg products in pails at its Gainesville facility to further investigate the issue.
  • The VNS Therapy SenTiva Generator System is used for Vagus Nerve Stimulation (VNS) therapy to reduce the frequency of seizures in adults and children over 4 years of age with partial onset seizures who have not responded to epilepsy medications. The VNS Therapy SenTiva Generator is also used for the treatment of major depressive episodes in patients 18 years of age or older who have not responded to antidepressant treatments.
    The system detects and responds to heart rate increases that may be associated with seizures or depressive episodes by sending mild pulses to the brain through the vagus nerve. The system consists of an implantable VNS Therapy generator, a lead and electrodes around the vagus nerve, and an external programming system used by health care providers to change stimulation settings.Who May be Affected
    Patients receiving VNS Therapy with the VNS Therapy SenTiva Generator System
    Health care providers who administer VNS Therapy to patients using the VNS Therapy SenTiva Generator System
    Hospital Risk Management departments with VNS Therapy SenTiva Generator Systems in their inventory
    What to Do
    On August 23, 2019 and August 26, 2019, LivaNova notified United States hospitals and healthcare providers of patients with an implanted VNS Therapy SenTiva Generator System about the recall through an Urgent Medical Device Recall Notification letter. On October 8, 2019, LivaNova sent healthcare providers a follow-up notification with actions patients and health care providers should take if they have the recalled device.
    Actions Patients Should Take
    Notify a health care provider immediately if there is a change in symptoms such as increase in seizures or depressive symptoms, or perceived loss of stimulation. Caregivers of children implanted with an affected device, should have the health care provider verify that the device is functioning properly.
    Make sure you and your health care provider continue to:
    With Magnet Mode enabled, continue using the magnet regularly to verify that stimulation is felt as described by the labeling (For Epilepsy symptoms).
    At the beginning of each office visit, the health care provider will examine the device and perform diagnostic testing per labeling to verify the device is programmed to the intended settings, such as programming at last visit, and per scheduled programming protocol.
    At the end of each office visit the health care provider will examine the device per labeling and verify that the device is programmed to the intended settings.
    Complete and give the completed Customer Response Form attached to the notification to your health care provider. The health care provider will fax the Customer Response Form to (281) 853-1248 or e-mail the form to M1000FieldAction@livanova.com.
    LivaNova is working with the FDA to mitigate this reset error. If your device has experienced a reset, please notify LivaNova and work with your health care provider to identify alternate therapy options, if appropriate. LivaNova will provide updates if new information becomes available.
    Health care providers and patients can identify whether implanted devices were distributed prior to a screening procedure intended to detect devices susceptible to unintended device disablement on the LivaNova website
    External Link Disclaimer
    .
  • GE Healthcare is recalling the Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestations because the bedside panels can be upright and look closed but not be securely latched. The portholes can also look closed when not securely latched. If a canopy cover is used, it can hold the bedside panel or porthole door closed without being securely latched. If an infant comes in contact with a bedside panel or porthole that is unlatched, the panel or porthole can disengage and fall open, no longer protecting the infant from falling.Giraffe Incubators and OmniBeds by GE Healthcare: Class I Recall – Due to Potential for Infants to FallBACKGROUND: Incubators and warmers are used for infant care in a hospital setting. Incubators are small beds enclosed in clear, hard plastic that is temperature-controlled for infants who are unable to maintain their body temperature on their own. Infant warmers are small beds with heaters over them to warm infants who are unable to maintain their body temperature on their own. Healthcare providers can give care to the baby through holes in the sides of the incubator, also called portholes.The firm has received 6 reports of infant falls with injuries such as skull fractures, hematoma and edema. No deaths were reported.RECOMMENDATION: On November 8, 2019 GE Healthcare sent an updated letter to customers stating that users can continue to use their Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation systems by following these instructions:
    1. Every time the bedside panel is closed, users must pull on the bedside panel to make sure the bedside panel is latched, and the red tab is no longer visible (see Figures 1 and 2).
    2. Users must pull on the porthole doors every time the bedside panel or porthole is closed to make sure the porthole door is latched (see Figure 3).
    3. Apply the safety warning labels that were included with the letter to the Incubator or OmniBed using the instructions provided.
    4. Review the user manual Addendum and place it with the Incubator or OmniBed User Manual.
    5. Place all three (3) of the provided “Giraffe Incubator/OmniBed Risk of Patient Fall” posters in prominent locations for healthcare staff and ensure the posters are displayed for the lifetime of the Incubator or OmniBed(s).
    6. Confirm that the information from the customer letter and user manual Addendum are properly disseminated to all users that handle the Incubator or OmniBed.
    7. Ensure that all hospital staff who open panels or portholes or otherwise come into contact with the device understand these instructions.
    8. Ensure that any spare bedside panels or end panels that are not installed on incubator or OmniBed units are appropriately labeled according to the instructions. Additional labels can be obtained from a local GE representative.
    9. Complete and return the provided form to document that all hospital staff who come into contact with the incubator or OmniBed are trained on the proper closing and latching of the devices and that the steps provided in the instructions are followed
  • Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.
    The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.
    Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.
    Glenmark’s Ranitidine Tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities. Of the 928 recalled lots of Ranitidine Tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
    Glenmark is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Glenmark ceased distribution of its Ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.
    To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall. The Ranitidine Tablets, USP, distributed by Glenmark are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
  • Emesa Foods, Taylor, MI is voluntarily recalling 23 cases and each case 6 containers of 800 gram of “Premium Sesame Tahini” 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, 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 product was distributed in states of Michigan and Texas and is sold in 800 grams (28.2 Oz). Expiration dates (2/25/2021) are printed on the side of the container.
    Product code, product description, UPC and expiration dates information:
    Product Code
    Product Description
    UPC
    Expiration Dates
    29826
    Premium Sesame Tahini
    850005298267
    02/25/2021
    No illnesses have been reported to-date in connection with the Emesa Foods Tahini.
    This potential problem was revealed as a result of a random sampling by the Michigan Department of Agriculture and Rural Development. Although we have not received the final laboratory reports, Emesa Foods is taking the precaution of recalling product with the product code listed above.
    Consumers who have purchased Emesa Foods Tahini with these codes should discontinue use and return it to the store of purchase for a full refund. Retailers that may have further distributed the recalled codes should share this notice with their customers. Retailers or consumers with questions may contact Recall Coordinator Mr. Filio at 248-660-0406 Monday to Friday from 8AM – 5PM.
  • CATSMO LLC. Of Wallkill, NY, out of an abundance of caution, is recalling Cold Smoked Salmon because it has the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    The recalled product was distributed in 11 states through retail stores and direct delivery as follows: NY, CT, NJ, MN, NC, FL, VA, MA, IL, PA and Washington D.C.
    The product comes in a vacuum-sealed plastic package in whole fillets, specialty cuts, 4 oz., 8oz., or 1lb. sizes and are either plain or flavored.
  • Ruiz Food Products Inc., a Florence, S.C. establishment, is recalling approximately 55,013 pounds of frozen, not ready-to-eat (NRTE) breakfast burrito products containing eggs, sausage, and cheese that may be contaminated with extraneous materials, specifically pieces of plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, NRTE breakfast burrito products were produced on October 15, 2019. The following products are subject to recall: [View Labels (PDF only)]
    3.38-lb. Value Pack, containing 12 individually wrapped, 4.5-oz. “EL MONTEREY Signature BURRITO EGG, SAUSAGE & CHEESE” with a “Best if Used By” date of 01/15/2021 and a lot code of 19288.
    The products subject to recall bear establishment number “EST 45694” printed on the value pack bag and the individual wrappings, next to the lot code. These items were shipped to retail locations nationwide.
    The problem was discovered when the firm notified FSIS of three consumer complaints involving pieces of white, semi-rigid plastic found in the product.
    There have been no confirmed reports of injuries due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
    Consumers with questions about the recall can contact Ruiz Foods Products Inc., Consumer Line at (800) 772-6474. Members of the media with questions about the recall can contact Pat Summers, Ruiz Foods Products Media Relations, at (559) 285-1100.
  • Tailor Cut Produce of New Jersey, is recalling its Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products because they have 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 recalled fruit products were distributed in Pennsylvania, New Jersey, New York and Delaware between November 15 and December 1, 2019.
    The product comes in 2/1 gallon cases with a date of production stamped on the side.
    The potential for contamination was noted after several patients fell ill in 4 hospitals in Pennsylvania.
    Production of the product has been suspended while FDA and the company continue their investigation as to the source of the problem.
    Distributors who have purchased the cut fruit products dated November 15 – December 1 are urged to quarantine them and to call for further instructions. Consumers with questions may contact the company at 732 246-2002.
  • White Castle has initiated a voluntary recall of a limited number of frozen 6 pack cheeseburgers, frozen 6 pack hamburgers, frozen 6 pack jalapeno cheeseburgers, and 16 pack hamburgers, 16 pack cheeseburgers for the possible presence of Listeria monocytogenes. Listeria monocytogenesis an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeriainfection can cause miscarriages and stillbirths among pregnant women.
    The voluntary recall will impact product on shelves at select retailers with best by dates ranging from 04 Aug 2020 to 17 Aug 2020. Any product with these dates on shelves is presently being removed. Any product with a best by date before or after these best by dates is not included in the voluntary recall.
    To date, public health officials have not reported any illness associated with these products.
    “Our number one focus is the safety of our customers and our team members, and as a family owned business, we want to hold ourselves to the absolute highest standards of accountability in all aspects of our business – and especially food safety,” said White Castle Vice President, Jamie Richardson.
    White Castle conducts frequent and regular quality assurance tests. A recent sample conducted by a third party laboratory of its frozen sandwiches from one manufacturing facility showed a presence of Listeria monocytogenes halting any shipment of product to customers. Since the problem was identified White Castle has not shipped any product from this facility to customers. Following rigorous safety testing protocols, all impacted production runs have been identified for destruction. White Castle has maintained complete control of all product produced at the facility since the first indication of a problem.
    White Castle is taking the following actions at the facility where the problem was identified:
    Intensive sanitation and cleaning with guidance from outside food safety experts.
    Aggressively elevating already strong food safety testing and manufacturing guidelines.
    Conducting comprehensive testing to confirm no presence of listeria in the facility. “This voluntary recall is precautionary and is the right thing to do,” said Richardson.
    Customers who may have purchased any of the products indicated (product codes listed below) are urged to dispose of them or return them to the store where they were purchased for an exchange or full refund and to consult with their physician regarding any medical questions.
    Customers may also contact White Castle at 1-800-843-2728.
  • TOPIC: Drugs, Dietary Supplements and Devices by Basic Reset and Biogenyx: Recall – Due to Consent Decree for Federal Violations

AUDIENCE: Consumer, Patient, Pharmacy

BACKGROUND: Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain.

ISSUE: The FDA is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree. Given these products do not comply with appropriate FDA standards, they have the potential to be unsafe or ineffective for their particular uses and could lead to adverse health impacts.

The FDA has not received any adverse event reports related to these products. For a complete list of affected products, please click on the “Read Recall” button below. For additional information, read the news release issued on December 10, 2019.

RECOMMENDATION: The FDA is reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products as they do not meet FDA regulations.

  • B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. The recalled blood administration sets are used to administer blood from a container to a patient’s vascular system through an IV catheter inserted into a vein or central venous catheter.
    B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. Blood set leakage may result in delay in therapy due to the need to replace the set and blood product or result in the potential for microorganisms to enter the circulatory system creating a risk of bloodstream infection. To date there have been no reports of serious injury or death.Product Catalog Number:
    Lot Number
    GUIDID
    Product Description:
    477005
    61679395
    04046955202799
    Outlook® Safety Infusion System Y-type Blood Set
    477005
    61685454
    04046955202799
    Outlook® Safety Infusion System Y-type Blood Set
    490293
    61681734
    04046964539657
    Y-type Blood Set
    490314
    61674868
    04046964527180
    Y-type Blood Set
    490314
    61677175
    04046964527180
    Y-type Blood Set
    490314
    61678259
    04046964527180
    Y-type Blood Set
    490314
    61685087
    04046964527180
    Y-type Blood Set
    490425
    61674871
    04046964813702
    Y-type Blood Set
    490425
    61680607
    04046964813702
    Y-type Blood Set
    490425
    61685094
    04046964813702
    Y-type Blood Set
    490530
    61674878
    04046955203321
    Y-type Blood Set
    490530
    61677192
    04046955203321
    Y-type Blood Set
    490530
    61678186
    04046955203321
    Y-type Blood Set
    490530
    61681736
    04046955203321
    Y-type Blood Set
    490530
    61685105
    04046955203321
    Y-type Blood Set
    NF5140
    61681745
    04046964187483
    Safeline® Y-Type Blood
    Set
    Product Catalog Number:
    Lot Number
    GUIDID
    Product Description:
    NF5140
    61685109
    04046964187483
    Safeline® Y-Type Blood
    Set
    V2500
    61674884
    04046964188633
    Y-Type Blood Set
    V2500
    61677634
    04046964188633
    Y-Type Blood Set
    V2500
    61678262
    04046964188633
    Y-Type Blood Set
    V2500
    61680625
    04046964188633
    Y-Type Blood Set
    V2500
    61685110
    04046964188633
    Y-Type Blood Set
    A total of 43,026 units of the recalled blood administration sets were manufactured between June 11, 2019 and August 23, 2019 and distributed between June 11, 2019 and September 27, 2019. B. Braun notified its distributors and customers by certified mail on November 20, 2019 and is arranging for the return of all recalled blood administration sets. Distributors and customers that have affected inventory should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST) for instructions to return the affected blood administration sets; and to arrange for either replacement of product or refund. The recalled blood administration sets were distributed only to the United States and Canadian markets.
    Consumers with questions regarding this recall, including arranging for replacement product or refund, can contact B. Braun Medical Inc.’s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.
    Adverse reactions or quality problems experienced with the use of this product should be reported to B. Braun’s Medical Information Department at 1-800-854-6851. Additionally, any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program:
    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.
    About B. Braun
    B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include ostomy and wound care, dialysis, nutrition, and pharmacy admixture. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
  • Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products. Cyclamate is an unapproved ingredient.
    The recalled Suantianyangmei Waxberry and Bingtangyangmei Waxberry were distributed nationwide in retail stores. These products come in 8.11 OZ (230G) clear plastic containers. Suantianyangmei Waxberry is with UPC code 6948576407226 and date 03.12.2020 stamped on the box and Bingtangyangmei Waxberry is with UPC code 6948576407219 and date 02.13.2020 stamped on the box.
    No illnesses involving these products have been reported to date.
    The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department’s Food Laboratory personnel revealed the presence of sulfites and cyclamates in these products which were not declared on the labels. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the Suantianyangmei Waxberry and Bingtangyangmei Waxberry revealed they contained undeclared sulfites 13.88 milligrams and 12.85 milligrams per serving, respectively.
    Consumers who have purchased 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Selina Lin at 516-261-9521.
  • UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached, with a Code of AA BEST IF USED BY 010820 CC 15:58 and UPC Code 711535509158. The recall is being issued for the potential presence of E. coli. During routine FDA sampling of the five-pound bag product, results were found to be positive for E.coli.
    E. coli can cause serious and sometimes life-threatening infections in infants, older people, pregnant women, and people with weakened immune systems. The most common symptoms of E. coli are diarrhea, abdominal cramps, nausea and vomiting, which develop within three or four days of eating contaminated food. The illness usually lasts about a week and most people recover without treatment. Guidance from FDA and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour and that all surfaces, hands and utensils should be properly cleaned after contact with flour or dough.
    To date, UNFI has not received any direct consumer reports of confirmed illnesses related to this product. This recall is being issued out of an abundance of care.
    This recall only affects the following code date of Wild Harvest® Organic All-Purpose Flour, Unbleached five-pound bags currently in stores or consumers’ pantries. No other types of Wild Harvest® Flour are affected by this recall.
    Wild Harvest® Organic All-Purpose Flour, Unbleached (sample label below) Package UPC: 711535509158 Best if Used by Date: 010820 CC 15:58 (can be found on top of the product, see sample below)
    Consumers are asked to check their pantries and dispose of the product affected by this recall. Consumers with questions may contact UNFI at 855-423-2630 (customer support is available seven days-a-week between 8:00 AM to 8:00 PM CST). Any consumers concerned about an illness should contact a physician.

1936 – The United Auto Workers union staged its first sit-down strike, at the Fisher Body Plant in Flint, MI.


(Photo: Library of Congress/Associated Press)blasts30p1Sit-down strikers read newspapers at General Motors’ Fisher Body plant in Flint, Mich., in 1937. Their sit-down strike, which lasted six weeks, began on Dec. 30, 1936

In 1936, the United Auto Workers union staged its first “sit-down” strike at the General Motors Fisher Body Plant No. 1 in Flint, Michigan. (The strike lasted until Feb. 11, 1937.) In 1942, a near-riot of bobby-soxers greeted the opening of Frank Sinatra’s singing engagement at the Paramount Theater in New York’s Times Square

for more … jsonline.com/story/life-green