Drug Recalls
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product
FOR IMMEDIATE RELEASE – 3/13/2023 – Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
FOR IMMEDIATE RELEASE – 4/3/2023 – Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution, SOFT HANDS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution, and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the presence of methanol.
Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitroso-dabigatran (NDAB) Impurity
FOR IMMEDIATE RELEASE- Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Food & Beverage Recalls
Karma Spices and Trading Company, LLC Issues Allergy Alert on Undeclared Milk in White Cheddar Cheese Popped Water Lily Seeds
Karma Spices and Trading Company, LLC of Walled Lake, Michigan is recalling White Cheddar Cheese Popped Water Lily Seeds, because it may contain undeclared Milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled White Cheddar Cheese Popped Water Lily Seeds were sold at retail stores in Michigan stores and online at www.karmawellnesskitchen.com.
The recalled product is white cheddar cheese popped water lily seed snack. The product is identifiable by the tan colored 1.5oz. standup pouch bag and artwork includes these words on front “white cheddar cheese-Popped water lily seeds”. Please also refer to the best by/lot number sticker located on back of the package. Lot numbers included are: 051222, 082222, 111622, 021323. The product UPC is 6 17201 89258 9.
Revolution Farms Announces the Voluntary Recall of Lettuce Because of Possible Health Risk
Revolution Farms of Caledonia, Michigan is voluntarily recalling the listed products packed between 3/3/23 and 3/11/23, because they have 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.
Wellness Natural USA Inc. Issues Allergy Alert on Undeclared Cashews in SimplyProtein® Peanut Butter Chocolate Crispy Bars
Wilmington, DE, March 31, 2023 – Wellness Natural USA Inc. of Wilmington, DE is voluntarily recalling a single lot of its SimplyProtein® Peanut Butter Chocolate Crispy Bar in the United States, which is sold in a 15-count variety pack that contains two other flavors, because it may contain an undeclared trace of tree nuts (cashews). People who have an allergy or severe sensitivity to cashew run the risk of a serious or life-threatening allergic reaction if they consume these products.
The recalled products were distributed in the United States in limited Costco stores in Arkansas, California, Washington DC, Kansas, Maryland, Oklahoma, Pennsylvania, Texas and Virginia.
The product comes in a 15-count variety pack which includes 5 Peanut Butter Chocolate Crispy Bars. The product is marked with a Best Before date of 05 Jan 2024 and Lot TN3005A on the bar wrapper (UPC 6 86207 80906 8) / Lot TN3005 (UPC 6 86207 00914 7) on the outside carton. The photographs below indicate Best Before date and lot number markings. The recall does not apply to any other Lot marking, Best Before date, or varieties of SimplyProtein® products, including the other two flavors contained in the 15-count variety pack.
Seven Seas International USA, LLC is Voluntarily Recalling Biltmore Smoked Sockeye Salmon Because of Possible Health Risk
Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 295 cases of Biltmore Smoked Sockeye Salmon with production lot R4058 because Listeria monocytogenes may be present in some product. The issue was discovered through routine regulatory testing conducted by the Florida Department of Agriculture and Consumer Services. Consumers who have purchased this product with this lot code are being advised not to consume it and return it to the store where it was originally purchased for a full refund. Listeria monocytogenes can cause serious and sometimes fatal infections, especially in preschool age children, older adults, or people who are immune compromised. Additionally, it can cause miscarriages and stillbirths in pregnant women. Only packages sold prior to 14th March 2023 which have a lot code R4058 printed on the clear plastic film that protects the product are affected by this recall, please check for this code, no other production codes are affected by this recall.
Gilster-Mary Lee Corp. Issues a Recall for Undeclared Milk Allergen in HyVee Hamburger Chili Macaroni Skillet Meal
FOR IMMEDIATE RELEASE – March 28, 2023 - Gilster Mary Lee, 10 Industrial Park, Steeleville Illinois is recalling one lot of HyVee Hamburger Chili Macaroni Skillet Meal, UPC 75450-08552 at the consumer level because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious life- threating allergic reaction if they consume this product.
The only lot involved is HyVee Hamburger Chili Macaroni Skillet Meal, packaged in 5.2-oz. cartons which have a Best By date of FEB 08 24 Y18 (UPC# 75450-08552). Consumers should return the product to the store for a full refund or discard it.
Salento Organics Issues Allergy Alert on Undeclared Milk in Dark Chocolate Fruit and Peanut Bites
Salento Organics of West Palm Beach, Florida is recalling its 4 ounce packages of Dark Chocolate Pitaya Bites, Dark Chocolate Goldenberry Bites, Dark Chocolate Mango Bites, Dark Chocolate Banana Bites, Dark Chocolate Pineapple Bites and Dark Chocolate Peanut Bites because they may contain undeclared milk.
People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Salento Organics products were distributed nationwide in retail stores and through mail orders.
North American Food Distributing Company, Inc. Issues Allergy Alert on Undeclared Soy in 16.9 Fl Oz of Kagome Worcester Sauce and 16.9 Fl Oz of Kagome Chuno Sauce
North American Food Distributing Company, Inc of West Sacramento, Ca is recalling 16.9 fl oz of Kagome Worcester Sauce and 16.9 fl oz of Kagome Chuno Sauce, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy or Soy products run the risk of serious or lifethreatening allergic reaction if they consume these products.
16.9 fl oz of Kagome Worcester Sauce and 16.9 fl oz of Kagome Chuno Sauce was distributed in Northern California through retail grocery stores throughout the area.
Second Nature Brands Issues Allergy Alert on Undeclared Wheat in Gluten Free Reese’s Pieces Brownie Brittle
Second Nature Brands of Madison Heights, MI, is recalling its 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle because they may contain undeclared wheat.
People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Gluten Free Reese’s Pieces Brownie Brittle were distributed nationwide in retail stores and through online orders.
The product comes in a 4-ounce pouch UPC 711747011562 marked with lot codes SG 1054 15/NOV/2023 1S and SG 1054 15/NOV/2023 2S on the backside of pouch.
Perfection Bakeries, d/b/a/ Aunt Millie’s Issues Allergy Alert on Undeclared Sesame in “Our Family Hot Dog Buns 8 Ct.”
Perfection Bakeries D/B/A Aunt Millie’s of Fort Wayne, IN. is recalling 8 ct. packages of Our Family® White Hot Dog Buns because they may contain undeclared sesame. People who have an allergy or severe sensitivity to sesame run the risk of serious or life- threatening allergic reaction if they consume these products.
The recalled “Our Family Hot Dog Buns 8 ct.” were distributed in retail stores in Michigan, Ohio, Indiana, and Illinois.
The product comes in a printed plastic package marked with “Our Family Hot Dog Buns 8 ct.” on the top and has a blue twist tie. The product UPC is 0-70253-75107-3, and include Best By Dates 4-9-2023 and earlier. One reaction has been reported to date in connection with this recall.
Medical Device Recalls
Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.
- This communication applies to the Readers used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems (all Reader serial numbers). This does not affect any of the FreeStyle Libre family of sensors.
- If not properly stored, charged, or used with the Abbott-provided yellow USB cable and power adapter, a potential exists for battery swelling and, in rare cases, extreme overheating, which may pose a fire hazard.
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