- J Deluca Fish Company Inc., doing business as Nautilus Seafood, a Wilmington, Calif. firm and the importer of record, is recalling approximately 69,590 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Additionally, the products were produced at a Vietnamese establishment that was not eligible to export Siluriformes fish to the United States.
The frozen Siluriformes items, specifically Yellow Walking Fish, were imported from Vietnam to the United States on various dates from August 2018 to January 2019. The following products are subject to recall: [View labels (PDF only)]
Varying weights of packages containing 2 pieces of “HEADLESS-CLEANED YELLOW WALKING FISH” “Clarias Macrocepphalus” “CA TRE VANG LAM SACH – CAT DAU” “FARM RAISED”.
Varying weights of packages containing 2 pieces of “WHOLE YELLOW WALKING FISH” “Clarias Macrocepphalus” “CA TRE VANG NGUYEN CON” “FARM RAISED”.
These items were shipped to distributors and retail locations nationwide.
The problem was discovered on May 22, 2019, during routine FSIS surveillance activities of imported 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. Consumers and members of the media with questions about the recall can contact Wayne Berman, Manager, J Deluca Fish Company Inc., at (310) 901-4596. - Sikorski Sausages Co., Ltd., a London, Ontario, Canada establishment, is recalling approximately 74 pounds of various imported meat and poultry sausage products that were not presented for import re-inspection into the United Sates, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The various ready-to-eat meat and poultry sausage items were imported on May 14, 2019. This spreadsheet contains a list of the products subject to the recall. [View Labels (PDF only)]
The products subject to recall bear Canadian establishment number “810” within the Canadian mark of inspection. These sausage items were shipped to a retail location in California and sold in varying weights behind the deli or meat counter.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 with questions about the recall can contact Michael Zoltanski, Customer Service Representative with Sikorski Sausages, at michaelz@sikorski.ca or (519) 317-8711. Members of the media with questions about the recall can contact Peter Sikorski, CEO of Sikorski Sausages, at peter@sikorski.ca or (519) 659-1219. - MedWatch Safety Alert was just added to the FDA Medical Device Recalls web page.TOPIC: FDA MedWatch Recall Notice – LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System by lntegra LifeSciences: Class I Recall – Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount StopcockAUDIENCE: Patient, Health Professional, Risk Manager, NeurologyISSUE: lntegra LifeSciences is recalling the LimiTorr & MoniTorr Drainage Systems due to reported complaints regarding: “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was leaking CSF.” This breakage occurs when there is over-bending of the stopcock most often related to the use of LimiTorr or MoniTorr in combination with a Fluid Filled Transducer.The device failure could result in infection (meningitis or ventriculitis), fever, headache, over drainage leading to subdural hematoma, over-drainage leading to the shifting of brain tissue (herniation), backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity (pneumocephalus), or death.
Serious patient injuries associated with infection and CSF leakage (over-drainage) related to the failure mode associated with this recall were reported. There were no deaths reported.
- The Village Company initiated a voluntary nationwide recall of the 22-ounce La Bella Extreme Sport Styling Gel. Four lots failed micro testing due to bacterial contamination, resulting in potential contamination of 2,377 cases (or 9,508 units). The bacteria found is Burkholderia cepacia and a group of related strains.
Burkholderia cepacia and group of related strains rarely cause infections in healthy people, but pose serious risk to individuals with cystic fibrosis, weakened immune systems, and chronic lung disease. If you are feeling ill after having used the product, consult with your doctor. Washing your hands, hair brush, combs and other hair items, counter tops and other surfaces with warm soapy water are good practices to help prevent the spread of bacteria.
The Village Company has not received any reports from consumers related to this recall. Consumers who have a product from any of the affected lots should stop using it immediately.
The recalled La Bella Extreme Sport Styling Gel was manufactured by Kapra Cosmetics, Inc. (Kapra) and distributed to retail starting March 5, 2019.
The following lot numbers have been recalled:
La Bella Extreme Sport Styling Gel
Lot Numbers: 19057B, 19072C, 19072E, 19072G
22-ounce bottle
The Village Company was alerted about the potential contamination on May 15, 2019. At that time, The Village Company immediately stopped shipping product, quarantined the remaining amount and is recalling the product from consumers.
The Village Company also immediately alerted the 14 affected customers to pull the product from shelves and destroy in the field. These nationwide retailers and wholesale distributors include Kroger (Food 4 Less and Ralphs), Stater Bros, Target, Heb, Cardinal Health, Certco, Cashco Distributors, Bashas, All Essentials, Yosemite Wholesale – Merced, Supervalu, AJ Express and Latin American Distributors, Inc.
The Village Company will provide a replacement product or refund to any consumer who has proof of purchase, which includes a receipt or a photo of the recalled lot code on the bottom of the bottle. Consumers should discard the product or return the product to The Village Company. If discarding the product, consumers should send an email to LaBellaExtremeSport@TheVillageCompany.com with the date they are discarding the product. Consumers may visit http://www.LaBellaExtremeSport.com
External Link Disclaimer
for additional instructions.
Consumers with questions may contact the company via our recall hotline at 612-268-2225 from Friday, May 24 – Monday, May 27 between the hours of 9:00am and 9:00pm EST. Starting Tuesday, May 28, consumers may contact customer service at 1-800-699-6852 weekdays between the hours of 9:00am and 6:00pm EST. Consumers may also contact the company via e-mail at LaBellaExtremeSport@TheVillageCompany.com.
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.
Complete and submit the report Online
Regular Mail or Fax: Download formor 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 - Sikorski Sausages Co., Ltd., a London, Ontario, Canada establishment, is recalling approximately 74 pounds of various imported meat and poultry sausage products that were not presented for import re-inspection into the United Sates, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The various ready-to-eat meat and poultry sausage items were imported on May 14, 2019. This spreadsheet contains a list of the products subject to the recall. [View Labels (PDF only)]
The products subject to recall bear Canadian establishment number “810” within the Canadian mark of inspection. These sausage items were shipped to a retail location in California and sold in varying weights behind the deli or meat counter.
The problem was discovered during routine FSIS surveillance activities of imported 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. - Brodt Zenatti Holding LLC of Jupiter, Florida is recalling all retail and bulk Karawan brand Tahini, sold in Jars: 450g (15.87 oz) and Buckets: 17kg (599.6 oz) that were imported from Palestine between the dates of December 2018 to April 2019 and SoCo Brand Tahini; 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.
Karawan brand Tahini was directly distributed to New York and Texas. We currently know that distributors have thereafter shipped the product to Massachusetts and Virginia.
Specific information on how to identify the Karawan brand Tahini product includes:
Name of product: Tahini
Brand name: Karawan Tahini
Unit size: Jar: 450g (15.87 oz) and Buckets: 17kg (599.6 oz)
Storage conditions: No refrigeration storage needed.
Expiration Date (s): Two years from the production. The expiration date is located on the lid of the containers.
Specific information on how to identify the SoCo brand Tahini product includes:
Name of product: Tahini
Brand name: SoCo Tahini
Unit size: Container: 380g (135 oz)
Storage conditions: No refrigeration storage needed.
Expiration Date (s): Two years from the production. The expiration date is located on the lid of the containers.
Four (4) illnesses have been reported to date.
This recall has been initiated due to New York City Department of Health and Mental Hygiene laboratory results from two samples of Karawan brand tahini testing positive for Salmonella. Brodt Zenatti Holding LLC has ceased the importation and distribution of the product as FDA and Brodt Zenatti Holding LLC continue their investigation as to what caused the problem.
Consumers who have purchased Karawan brand tahini or SoCo brand Tahini are urged to destroy it or return it to the place of purchase for a full refund. Consumers with questions may contact Brodt Zenatti Holding LLC at 305-570-9050, Monday through Friday, from 9:00 am to 5:00 pm.
Richwell Group, Inc., doing business as Maxfield Seafood, a City of Industry, Calif. firm and the importer of record, is recalling approximately 154,560 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Additionally, the products were produced at a Vietnamese establishment that was not eligible to export Siluriformes fish to the United States.
The frozen Siluriformes items, specifically Yellow Walking Fish, were imported from Vietnam to the United States on various dates from March 2018 through January 2019. The products have a shelf life of two years. The following products are subject to recall: [View labels (PDF only)]
Varying weights of packages containing 2 pieces of “FARM RAISED INDIVIDUALLY QUICK FROZEN” “FROZEN HEADLESS YELLOW WALKING FISH Clarias macrocephalics”.
Varying weights of packages containing 3 pieces of “FARM RAISED INDIVIDUALLY QUICK FROZEN” “FROZEN HEADLESS YELLOW WALKING FISH Clarias macrocephalics”.
Varying weights of packages containing 2 pieces of “FARM RAISED INDIVIDUALLY QUICK FROZEN” “FROZEN YELLOW WALKING FISH Clarias macrocephalics”.
Varying weights of packages containing 3 pieces of “FARM RAISED INDIVIDUALLY QUICK FROZEN” “FROZEN YELLOW WALKING FISH Clarias macrocephalics”.
These items were shipped to retail locations nationwide.
The problem was discovered on May 22, 2019, during routine FSIS surveillance activities of imported products.
There have been no confirmed reports of adver
- Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, organ damage or death. To date, Heritage has not received adverse event reports related to this event. Consumers with questions regarding this recall should contact Qualanex at 1-800-505-9291 Monday – Friday, 8:00 am – 5:00 pm, EST and or recall@qualanex.com. Any adverse reactions or quality problems associated with the use of this product may be reported to ProPharma at 1-866-901-3784 at any time, and any such problems may also be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species.
- ADM Milling Co. is recalling all five-pound bags of Baker’s Corner All Purpose Flour packaged for ALDI in select markets because of the potential presence of E.coli, which was discovered during testing of a five-pound bag of Baker’s Corner All Purpose Flour by the Rhode Island Department of Health.
This E.colistrain found in the bag has been linked to 17 illness in eight states. The food source of the E.coli strain for all cases remains under investigation, but out of an abundance of caution, ADM is expanding its previous recall notice of only two specific lots to include all Baker’s Corner All Purpose
Flour five-pound bags currently in distribution that were manufactured for ALDI at ADM’s flour mill in
Buffalo, New York. The recall includes products distributed in select stores in 11 states: Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.
ADM Milling is working directly with ALDI, which has already recalled all potentially impacted products from store shelves in the region. ADM Milling is conducting an in-depth investigation to determine the cause of the contamination and is working closely with regulators throughout this process.
ADM reminds customers and consumers that flour is not ready-to-eat and must be thoroughly cooked before eating to prevent illness from possible bacteria in the flour. Do not eat or play with raw dough, and wash hands, utensils and surfaces after handling. Any consumers concerned about an illness should contact a physician.
If customers have product affected by this voluntary recall, they should discard it immediately or return it to their local ALDI store for a full refund. Please direct any customer inquiries for ADM Milling to 800-422-1688 between the hours of 8 a.m. and 4:30 p.m. Central Time Monday through Friday.
About ADM
For more than a century, the people of Archer Daniels Midland Company (NYSE: ADM) have transformed crops into products that serve the vital needs of a growing world. Today, we’re one of the world’s largest agricultural processors and food ingredient providers, with approximately 40,000 employees serving customers in nearly 200 countries. With a global value chain that includes approximately 450 crop procurement locations, more than 330 food and feed ingredient manufacturing facilities, 62 innovation centers and the world’s premier crop transportation network, we connect the harvest to the home, making products for food, animal feed, industrial and energy uses. Learn more at http://www.adm.com - MedWatch Safety Alert was just added to the FDA Medical Device Safety, Letters to Health Care Providers web page.TOPIC: UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors – Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy ProceduresAUDIENCE: Gastroenterology, Health Professional, Risk ManagerISSUE: The FDA is issuing this letter to announce the FDA clearance of a modified Erbe USA Inc. (Erbe) ERBEFLO port connector designed to help reduce the risk of cross-contamination that was identified in FDA’s
- MedWatch Safety Alert was just added to the FDA Medical Device Recalls web page.TOPIC: DxH 800, DxH 600 and DxH 900 Hematology Analyzers by Beckman Coulter Life Sciences: Class I Recall – Due to Sporadic Erroneously Elevated Platelet Count Results Without Flags or System MessagesAUDIENCE: Health Professional, Patient, Risk ManagerISSUE: Beckman Coulter is recalling the DxH 800, DxH 600, and DxH 900 Hematology Analyzers due to sporadic erroneously elevated platelet count results without flags or system messages, meaning there is no way for the laboratory operator of the test to recognize the error. Inaccurate platelet counts may cause serious adverse health consequences such as increased risk for life-threatening bleeding associated with withholding platelet transfusion or inappropriate decisions for surgeries or invasive procedures; delayed or missed diagnosis of serious medical conditions, including thrombotic microangiopathy and heparin induced thrombocytopenia. http://s2027422842.t.en25.com/e/er?utm_campaign=FDA%20MedWatch%20-%20UPDATE%20On%20Risk%20of%20Cross-Contamination%20from%20Multi-Patient%20Use%20Endoscope%20Connectors&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=8067&elqTrackId=284856C243E893A822E84304FBECCA6C&elq=ea810948becd436ba374765fe8711c53&elqaid=8160&elqat=1
- Aurora Packing Company, Inc., a North Aurora, Ill. establishment, is recalling approximately 62,112 pounds of raw beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw beef products were packaged on April 19, 2019. This spreadsheet contains a list of the products subject to recall.[View Labels(PDF only)]
The products subject to recall bear establishment number “EST. 788” inside the USDA mark of inspection. These items were shipped nationwide for further distribution and processing.
The problem was discovered during traceback activities in response to random sample testing by FSIS. 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. E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS is concerned that some product may be in institutional facility freezers. Institutions who have purchased these products are urged not to use 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.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume product that has been cooked to a temperature of 165°F. The only way to confirm that beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, https://www.fsis.usda.gov/safetempchart.
Consumers and members of the media with questions about the recall can contact David Stewart, Director of Sales and Marketing for Aurora Packing Company, Inc., at (630) 897-0551. - Caito Foods LLC., an Indianapolis, Ind. establishment, is recalling approximately 1,767 pounds of salad with chicken products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy, a known allergen, which is not declared on the product label.
The ready-to-eat salads with chicken items were produced on May 12 through May 15, 2019. The following products are subject to recall: [View Labels (PDF only)]
13.5-oz. plastic square bowl packages containing “Greek Salad with Chicken with Chicken Breast & Red Wine Olive Oil Vinaigrette Dressing” and Sell By dates ranging from 05/18/19 through 05/21/19 represented on the label.
11.25-oz. plastic square bowl packages containing “Tuscan Style Caesar Salad with Grilled Chicken With Grilled White Chicken Tossed In Pesto” and Sell By dates ranging from 05/18/19 through 05/21/19 represented on the label.
The products subject to recall bear establishment number “P-39985” inside the USDA mark of inspection. These items were shipped to Kroger retail locations in Illinois, Indiana, Kentucky, Michigan, and Ohio.
The problem was discovered by the recalling firm during label verification activities.
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 Caito Foods LLC.’s Consumer Feedback Line at (844) 467-7278. Members of the media with questions about the recall can contact Meredith Gremel, Organizational Communications, Spartan Nash, at (616) 878-2830. - Vienna Beef Ltd., a Chicago, Ill. establishment, is recalling approximately 2,030 pounds of beef frank links products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The beef frank links items were produced on May 2, 2019. The following products are subject to recall: [View Labels (PDF only)]
10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 8’s 10#” with case code 013180 and package code 9122 represented on the label.
10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 11’s 10#” with case code 013312 and package code 9122 or 9123 represented on the label.
10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 7” 9’s 10#” with case code 013490 and package code 9122 or 9123 represented on the label.
The products subject to recall bear establishment number “EST. 1” inside the USDA mark of inspection. These items were shipped to food service locations in Illinois, Indiana, and Wisconsin.
The problem was discovered by the establishment and reported to FSIS.
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 Tom McGlade, VP of Marketing, Vienna Beef Ltd., at (773) 435-2204. - Seven Seas International USA, LLC of St. Petersburg, Florida is recalling its 4 oz. Biltmore Smoked Sockeye 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 4 oz. Biltmore Smoked Sockeye Salmon was distributed only in Florida by Publix Grocery stores. The product can be identified by its production code, which is a four digit code printed on the clear vacuum bag that contains the product. The Biltmore Smoked Sockeye product is sold in 4 oz. black printed carton sleeves with the Brand name “Biltmore” printed on the front, containing the smoked sockeye product in a clear vacuum bag, the product is displayed on a gold plate. Only products with Production Code 41CM and a sell by date of 23rd May 2019 are subject to this recall, all other production codes are not part of this recall. The product carries the following UPC code: 007-36211-88774
No illnesses have been reported to date.
The recall was the result of a routine sampling program by the Florida Department of Agriculture, which revealed that some of the finished product samples tested positive for the bacteria. Seven Seas and Publix out of an abundance of caution have decided to voluntarily remove all of the Biltmore Smoked Salmon of this particular production code. All subsequent production codes were tested and found not to contain the bacteria. The FDA and Seven Seas International USA, LLC continue their investigation as to what caused the problem.
Publix Customers who have purchased this product are being advised not to consume it and return it to the store where it was originally purchased for a full refund.
Customers who have additional questions or concerns may contact Seven Seas International USA, LLC from 6 AM EST to 6 PM EST at 1(888) 627-5668 or visit their website at http://www.7siusa.com - Crab House Trading Corp., a Los Angeles, Calif. establishment, is recalling approximately 36,040 pounds of frozen Siluriformes products, specifically yellow walking fish, that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The following products are subject to recall: [View Labels (PDF only)]
Various weight vacuum-sealed packages containing frozen “TRIPLE PEARL HEADLESS-CLEANED YELLOW WALKING FISH CA TRE VANG LAM SACH – CAT DAU” and may have best before dates of 20210203 or 20201225 or no date at all represented on the label.
These items were shipped to retail and wholesale locations in California.
The problem was discovered by FSIS during follow-up surveillance activities.
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 Jose Benitez, Office Manager, Crab House Trading Corp., at (213) 627-6398. - Seven Seas International USA, LLC of St. Petersburg, Florida is recalling its 4 oz. Biltmore Smoked Sockeye 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 4 oz. Biltmore Smoked Sockeye Salmon was distributed only in Florida by Publix Grocery stores. The product can be identified by its production code, which is a four digit code printed on the clear vacuum bag that contains the product. The Biltmore Smoked Sockeye product is sold in 4 oz. black printed carton sleeves with the Brand name “Biltmore” printed on the front, containing the smoked sockeye product in a clear vacuum bag, the product is displayed on a gold plate. Only products with Production Code 41CM and a sell by date of 23rd May 2019 are subject to this recall, all other production codes are not part of this recall. The product carries the following UPC code: 007-36211-88774
No illnesses have been reported to date.
The recall was the result of a routine sampling program by the Florida Department of Agriculture, which revealed that some of the finished product samples tested positive for the bacteria. Seven Seas and Publix out of an abundance of caution have decided to voluntarily remove all of the Biltmore Smoked Salmon of this particular production code. All subsequent production codes were tested and found not to contain the bacteria. The FDA and Seven Seas International USA, LLC continue their investigation as to what caused the problem.
Publix Customers who have purchased this product are being advised not to consume it and return it to the store where it was originally purchased for a full refund.
Customers who have additional questions or concerns may contact Seven Seas International USA, LLC from 6 AM EST to 6 PM EST at 1(888) 627-5668 or visit their website at http://www.7siusa.com
External Link Disclaimer
. - MIBO Fresh Foods LLC, a Fort Worth, Texas establishment, is recalling approximately 1,460 pounds of salad with meat 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 anchovies, a known allergen, which is not declared on the product label.
The ready-to-eat Chef salad with ham and turkey items was produced on May 10 and May 13, 2019. The following products are subject to recall: [View Label (PDF only)]
9.65 oz. clear plastic packages containing “H.E.B. MEAL SIMPLE CHEF SALAD with Homestyle Ranch Dressing” and “Best By” dates of 05-18-19 and 05-20-19 represented on the label.
The products subject to recall bear establishment number “EST. P-27399” inside the USDA mark of inspection. These items were shipped to retail stores in Texas.
The problem was discovered by a retail store when the mislabeled products were being unboxed to be placed on the retail store shelves.
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.onsumers with questions about the recall can contact Debbie Patterson, Business Development, MIBO Fresh Foods LLC, at (817) 882-9600. Members of the media with questions about the recall can contact Uzor Nwoko, President, MIBO Fresh Foods LLC, at (817) 882-9600. - Deshi Distributors LLC. of Jamaica, NY, is recalling its 3.5 oz, 7 oz and 14 oz packages of Deshi “Golden Raisins” because they contained 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 Golden Raisin with “undeclared sulphite” was distributed in New York, New Jersey, Pennsylvania, and Michigan and through delivery to retail stores.
The product comes in a 3.5 oz, 7 oz. and 14 oz. clear plastic package. UPC codes of Deshi Golden Raisin products are as follows: 3.5 oz is 691035359586; 7 oz. is 691035360179; and 14 oz. is 691035360483.
No illness or allergic reactions involving this product have been reported to date.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspector and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 7 oz. packages of Deshi “Golden Raisin” which were not declared on the label. The same raisins were packaged in 3.5 oz and 14 oz packages and are included in this recall.
Consumers who have purchased 3.5 oz, 7 oz and 14 oz packages of Deshi “Golden Raisins” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-291-1205 from 9 am to 5 pm Eastern Time. - Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.
Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.Product Description
NDC Number on Carton
NDC Number on Packet
Lot Number
Expiration Date
Distribution Dates
Promacta for Oral Suspension
0078-0972-61
0078-0972-19
8H57901589
09/2020
1/2/19 – 2/11/19
Promacta for Oral Suspension
0078-0972-61
0078-0972-19
9H57900189
12/2020
2/11/19 – 4/17/19
Promacta for Oral Suspension
0078-0972-61
0078-0972-19
9H57900289
12/2020
3/6/19 – 4/2/19
Consumers who have impacted product with these lot numbers and NDC numbers in their homes should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions on how to return recalled product. For all additional questions, please contact Novartis at 1-888-NOW NOVA (8:30 AM – 5:00 PM EST, Monday through Friday). - Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths Recalled Product(s): Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
Model Numbers: 830515F and 830705F
Lot Numbers: All lots expiring within 15 months. Lot numbers include: 59971507, 61068488, 61135027, 61176259, 61176335, 61209914, 61230764, 61245298, 61252231, 61252473, 61288724, 61332460, 61339380, 61350747, 61371827, 61393284, 61408923, 61415949, 61427629, 61453869, 61478583, 61481224, 61491734, 61516358, 61524807, 61532783, 61542460, 61552718, 61561749, 61569309, 61579845, 61719588, 61825706, 61846022, 61135026, 61046484, 61146229, 61176182, 61230763, 61252229, 61252230, 61252471, 61270367, 61321210, 61329796, 61350746, 61361008, 61369040, 61435190, 61444420, 61491732, 61516362, 61532782, 61542459, 61561748, 61569308, 61687687, 61697835, 61731942, 61809420.
Manufacturing Dates: December 22, 2017 to January 18, 2019
Distribution Dates: January 9, 2018 to February 25, 2019
Devices Recalled in the U.S.:reported.If you have unused product to return, contact Edwards Customer Service at 1-800-424-3278 option 1, to obtain a Returned Good Authorization (RGA) number.
Complete the acknowledgement form and fax to Edwards Customer Service at 1-800-422-9329 or 949-809-5467 within 10 days from receipt of the notification. - Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead. According to FDA instruction, lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing.
The recalled products were mostly sold locally in Chicago area at HoliCare clinics and a limited quantity were also distributed through mail orders.
The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing (MET-CLS) tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing (MET-CLS) tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.
No illnesses have been reported to date.
The recall was initiated after it was discovered based on sampling by U.S. Food and Drug Administration that the products contained high levels of lead which exceeded the new daily limit guidelines of 3 µg per day for children, the 12.5 µg per day for adults which we were informed by FDA on May 1, 2019.
The sale of these products has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem. Consumers who have purchased these products should not consume them and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-630-654-0617 central standard time, Monday to Friday, from 9:00AM to 4:30PM. - Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .
- Santa Fe Importers, Inc., a Long Beach, Calif. establishment, is recalling approximately 1,589 pounds of ready-to-eat (RTE) chicken meatball products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy, a known allergen, which is not declared on the products label.
The frozen, RTE chicken Thai-style meatballs were produced and packaged on April 24, 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.
226 cases containing “lemonade CHICKEN THAI STYLE MEATBALL” with packaging date “04/24/2019” and case code “114-102130” on the labels.Consumers and members of the media with questions about the recall can contact Jorge Endara, General Manager of Santa Fe Importers, Inc., at (562) 437-7775 or at Jorge@SanteFeImporters.com.
The products subject to recall bear establishment number “EST. P-4118” inside the USDA mark of inspection. These items were shipped to a distribution center in California and packed for Lemonade restaurants as indicated on the label.
Medtronic Pacemakers: Safety Communication
- Affected Medtronic implantable pacemaker and CRT-P device models include:• Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
• Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
• Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
• Serena models: W1TR02, W1TR05, W4TR02, W4TR05
• Solara models: W1TR03, W1TR06, W4TR03, W4TR06 - Cargill’s animal nutrition business is conducting a voluntary recall of select Southern States® feed due to aflatoxin levels that exceed FDA’s action levels. The affected products, which were manufactured and sold in the eastern United States, were removed from retail shelves throughout February, March, and April 2019. Livestock, horses, and poultry exposed to aflatoxin are at risk of exposure to several health hazards.Aflatoxicosis has the same acute and chronic adverse effects and health consequences across all species and age classes (immature and mature). Immature animals are more sensitive to aflatoxins. Acute aflatoxicosis may result in generalized hemorrhage, bloody diarrhea and death in 1-3 days. In addition, aflatoxin toxicity can cause reduced feed intake, reduced weight gain, liver damage, jaundice, and eventually death.No adverse health effects to animals have been reported to date. Nonetheless, Cargill is taking this voluntary step out of an abundance of caution. The affected products were manufactured at Cargill’s Cleveland, North Carolina, facility. Cargill first learned of the issue when it received a notification from the North Carolina Department of Agriculture of test results showing that a single lot of a specific Southern States product contained elevated levels of aflatoxin. Cargill has identified and corrected the root cause.
- Out of an abundance of caution, Mecox Bay Dairy, LLC, is recalling their Mecox Sunrise washed-rind Tomme style cheese 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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
This cheese was distributed and sold at seven retail locations and one restaurant on Eastern Long Island, NY, and served at one restaurant in Chicago, IL. The product comes in a clear plastic package marked with “Mecox Sunrise” cheese label. As of the date of this release, all affected Mecox Sunrise has been removed from all stores and restaurants.
No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by New York State Agriculture and Markets Division of Milk Control revealed the presence of Listeria monocytogenes in a sample of Mecox Sunrise cheese.
The production of the product has been suspended while FDA, New York State Agriculture and Markets, and Mecox Bay Dairy continue to investigate the source of the problem. Consumers who have purchased any “Mecox Sunrise” cheese are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company between 8:00am and 6:00pm EST at 631-537-0335. - Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall. Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .
- A MedWatch Safety Alert was added to the FDA Recalls webpage.TOPIC: Mycophenolate Mofetil for Injection by Par Pharmaceutical: Recall – Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted ProductAUDIENCE: Patient, Health Professional, Risk Manager, PharmacyISSUE: Endo International, announced on May 1, 2019, that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling Lot# AD812 (expiry 09/2020) of Mycophenolate Mofetil for Injection, to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.
- Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 11,829,517 million pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The problem was discovered when FSIS received two consumer complaints of extraneous material in the chicken strip products. FSIS is now aware of six complaints during this time frame involving similar pieces of metal with three alleging oral injury.
The frozen, ready-to-eat chicken strip items were produced on various dates from Oct. 1, 2018 through March 8, 2019 and have “Use By Dates” of Oct. 1, 2019 through March 7, 2020. The chart contains a list of the products subject to recall.[View Labels (PDF only)]
The products subject to recall bear establishment number “P-7221” on the back of the product package. These items were shipped to retail and Department of Defense locations nationwide, for institutional use nationwide and to the U.S. Virgin IslandsConsumers with questions about the recall can contact Tyson Foods Consumer Relations at 1-866-886-8456. Members of the media with questions about the recall can contact Worth Sparkman, Public Relations Manager, Tyson Foods, Inc., at Worth.Sparkman@Tyson.com (479) 290-6358. - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death).
- MedWatch Safety Alert was just added to the FDA Recall webpage. TOPIC: Bevacizumab 1.25mg/0.05mL 31G Injectable by AmEx Pharmacy: Recall – Due to Reported Defective Delivery System
AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager
ISSUE: The Monoject Syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient.
The additional force needed to express the drug product could potentially result in damage to the eye while the needle is in the eye. To date, AmEx Pharmacy has received three reports associated with the Lot being recalled as either being difficult to express, two of which, resulted in an Adverse Drug Event.
- Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.
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