Drug and Supplement Recalls
C&A Naturistics recalls AK Forte Dietary Supplement
FOR IMMEDIATE RELEASE – 10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot be marketed as dietary supplements. AK Forte tablets is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in AK Forte may cause serious side effects when combined with other medications. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. To date, C&A Naturistics has not received any reports of adverse events related to this recall.
STASKA Pharmaceuticals Inc. recalls STASKA Pharmaceuticals Ascorbic Acid Solution for Injection
FOR IMMEDIATE RELEASE – 10/10/2024 – Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.
The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.
To date, STASKA PHARMACEUTICALS has not received any reports of the presence of particulate matter, nor any adverse events related to this recall. This risk is further reduced as the product label contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering.
Food and Beverage Recalls
Acme Smoked Fish Corporation recalls Kirkland Signature Smoked Salmon
BROOKLYN, NY – October 25, 2024 – Acme Smoked Fish Corporation is issuing a recall of 111 cases of Kirkland Signature Smoked Salmon in twin 12oz package, UPC 0 96619 25697 6, Lot# 8512801270, Best-by-Date 11/13/2024 due to laboratory testing confirming Listeria monocytogenes on October 21, 2024. 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.
This product was distributed between October 9, 2024 to October 13, 2024. The product was distributed to the Southeast Costco Distribution Center located in West Palm Beach, Florida and Costco Warehouse stores in Florida.
To date there have been no reported illnesses linked to the recall.
Dakota Tom’s Sandwiches recalls Dakota Tom’s Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler
FOR IMMEDIATE RELEASE- Dakota Tom’s Sandwiches Corsica, SD is voluntarily recalling our Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler due to the burger patty being included in a recall from an outside supplier (BrucePac). The ingredient supplier (BrucePac) recall is due to possible Listeria monocytogenes contamination.
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.
Church Brothers, LLC recalls Multiple brand names Green Onions
Church Brothers Farms Recall Green Onions Due to Possible Health Risk
Salinas, CA, October 18, 2024 (For Distribution) - Church Brothers, LLC (“Church Brothers Farms”) is voluntarily recalling 1271 cases of green onions because of 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.
Distribution was limited to a small number of retail and foodservice customers in Canada and USA (Alabama, California, Connecticut, Florida, Georgia, Illinois, New York, Oklahoma, Pennsylvania, Tennessee, Virginia). Church Brothers Farms has notified these customers and is working with them to ensure rapid compliance with the recall.
Albertsons Companies recalls Multiple Store Brands ReadyMeals and store-made deli items
Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Albertsons Companies has voluntarily recalled 12 types of ReadyMeals and store-made deli items, supplied by Fresh Creative Foods, due to possible Listeria monocytogenes contamination. The recall was initiated because these products contain a recalled ready-to-eat chicken ingredient supplied by BrucePac of Durant, Okla., which was found to be contaminated with Listeria monocytogenes during routine tests by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). You can find the FSIS recall notice in the link in the article.
Listeria monocytogenes is an organism that 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. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
Consumers who have purchased these items are urged not to consume these products and to dispose of them or return the items to their local store for a full refund. Anyone concerned about an injury or illness should contact a healthcare provider.
Con Yeager Spice Company recalls Trail Bologna Meat Processing Kit
The Con Yeager Spice Company of Zelienople, PA, is recalling its TRAIL BOLOGNA MEAT PROCESSING KITS, because they may contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and wheat run the risk of serious or life-threatening allergic reaction if this product is consumed.
The recalled Trail Bologna Meat Processing Kits were distributed nationwide through wholesale distribution, retail stores, and mail order via (link in the article).
Fresh Express Incorporated recalls Gourmet Café Chicken Caesar Salad Bowl
Fresh Express is Voluntarily Recalling a Limited Number of Gourmet Café Chicken Caesar Salad Bowls
Fresh Express is voluntarily recalling a limited number of Gourmet Café Chicken Caesar Salad Bowls due to the inclusion of recalled chicken items from BrucePac, an outside ingredient supplier. The BrucePac recall is due to possible Listeria monocytogenes contamination. The fresh vegetable components are not impacted by this recall.
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.
The salad bowls were distributed in the following states: CA, LA, TX, WA.
Grand Central Bakery recalls Grand Central U-Bake Pie Crust, U-Bake Apple Pie, U-Bake Marionberry Pie, U-Bake Chicken Pot Pie
October 25, 2024, Grand Central Bakery Portland, OR and Seattle, WA is recalling U- Bake frozen pie products and frozen pie dough because they may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product
The affected U-Bake Pie Crust, U-Bake Apple Pie, U-Bake Marionberry Pie, and U-Bake Chicken Pot Pie products have expiration dates between 02/01/2025 and 04/20/2025. These pie products were sold between August 1, 2024, and October 20, 2024, and are packaged in clear plastic packaging with Grand Central Bakery branded sticker labels containing product identity. The expiration date sticker can be found on the exterior of the packaging.
One Roof, LLC. recalls Atwater’s Tarts
Atwater’s Issues Allergy Alert on Undeclared Tree Nuts in “Spider Web Tart”
Atwater’s of Baltimore, MD, is recalling its clam shell packages of spider web tarts sold 10/19/24 and 10/20/24 because they contain undeclared almond flour. People who have allergies to tree nuts run the risk of a serious or life-threatening allergic reaction if they consume these products.
The recalled spider web tarts were distributed on 10/19/24 and 10/20/24 at the following farmers markets located in the MD/DC/VA area: Arlington Courthouse, Falls Church, H Street, Mount Pleasant, Silver Spring, Dupont Circle, Greenbelt, and Westover. The product was in a clear clam shell plastic package marked with a green Atwater’s “Spider Web Tart” label on top and a Julian date of 292 labeled on the bottom.
No illnesses have been reported to date in connection with this problem and none were sold in retail stores.
Sprouts Farmers Market recalls Sprouts Chicken Street Taco Meal Kit
Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Sprouts Farmers Market has voluntarily recalled select lots of our Chicken Street Taco kits supplied by Fresh Creative Foods on 10/11/2024, due to possible Listeria monocytogenes contamination.
The affected product lots of the following product:
- Chicken Street Taco Meal Kit (UPC 205916813991; Best by Date 9/2/2024-11/7/2024)
No illnesses have been reported to date.
TreeHouse Foods, Inc. recalls Multiple brand names Frozen Waffle Products
OAK BROOK, Ill., Oct. 18, 2024 /PRNewswire/ -- TreeHouse Foods, Inc. (NYSE: THS) is voluntarily recalling certain frozen waffle products listed below due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that 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 headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
The recalled products were distributed throughout the United States and Canada and packed in various formats under the brand names listed in the article.
TreeHouse Foods, Inc. recalls Multiple brand names Frozen toaster waffles, Belgian waffles and pancakes
OAK BROOK, Ill., October 22, 2024 – TreeHouse Foods, Inc. (NYSE: THS) is expanding its voluntary recall to include all products manufactured at one facility and still within their shelf-life. The recall is expanded to include frozen toaster waffle, Belgian waffle and pancake products, due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that 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 headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
Recalled products were distributed throughout all states and provinces within the United States and Canada and packed in various formats under the brand names listed below. Consumers and retailers can identify the UPC on the back of the carton, and the Lot Code and Best By Date for these products (ranging from 12 to 18 months, depending on the product) on the end of the carton. Photos of the affected products can also be found in the link in the article.
Medical Devices Recalls
Medtronic plc recalls Medtronic MiniMed™ 600 series or 700 series insulin pumps
Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue
GALWAY, Ireland - October 4, 2024 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue. The FDA has classified this action as a class I recall.
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