Drugs
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
FOR IMMEDIATE RELEASE - DEERFIELD, Ill., AUG. 5, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.
Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.
B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
BETHLEHEM, PA - August 8, 2024 – B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Food & Beverage Recalls
Bonbon - A Swedish Candy Co.. Issues Allergy Alert on Undeclared Almonds, Wheat and Nuts in Marabou Sea Salt 200g Chocolate Bar
BonBon - A Swedish Candy Co. of New York, NY is recalling every Marabou Sea Salt chocolate bar, because it may contain undeclared almonds, wheat, and nuts. People who have an allergy or severe sensitivity to almonds and wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
Marabou Sea Salt was distributed in BonBon retail stores located at 130 Allen St, 1220 Lexington Ave and 705 Driggs Ave in New York City and was sold alongside other imported packaged goods.
The product can be identified by the ‘Marabou’ trademark font and logo, yellow plastic packaging and the word ‘havvsalt:’ the Swedish word for ‘sea salt.’ The product is a flat chocolate bar (9” x 4”) and weighs 185g. The expirations and production codes of the implicated inventory is 04.09.2024 and 09.11.2024 as well as OUV0134912 and OUV0140643.
Urgent Food Recall of Full Circle Market Coconutmilk Chocolate Almond Crunch Non-Dairy Frozen Dessert Due to Undeclared Cashew
AUGUST 06, 2024, Fort Walton Beach, FL - G.S. Gelato & Desserts, Inc. is recalling a limited amount of Full Circle Market Coconutmilk Chocolate Almond Crunch Non-Dairy Frozen Dessert 1 Pint/16 fl.oz. paper cartons, Lot 041624L2 BBD 10/15/2025, UPC 0 36800 46964 8, because it contains undeclared cashew. Lid displays “Nature’s Promise” brand Cashewmilk Chocolate Almond Crunch Non-Dairy Frozen Dessert. Carton displays “Full Circle Market” brand Coconutmilk Chocolate Almond Crunch Frozen Dessert. The ingredient list does not include cashew. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reactions if they consume the affected products.
Please see the attached product photos for ease of identifying the product.
Product was distributed to distribution centers carrying the Full Circle Market brand within the following states: Georgia, Massachusetts, and New York. Product was sent to retail stores located in New York, Massachusetts, Maine, New Hampshire, Vermont, New Jersey, Connecticut, Rhode Island. The product was shipped between April 18, 2024. – July 11, 2024
No adverse reactions have been reported to date.
North Fish USA Inc. Recalls “Cold Smoked Capelin” Because of Possible Health Risk
North Fish USA Inc of Hallandale, FL is recalling the imported 9-ounce packages of "Cold Smoked Capelin," because the product was found to be over 5” in length and uneviscerated, as such having potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled
The sale of uneviscerated fish over 5” in length may contain Clostridium botulinum spores as they are more likely to be concentrated in the viscera than any other portion of the fish. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
Perrigo Issues Voluntary Recall of One Batch of Premium Infant Formula with Iron Milk-Based Powder Due to Elevated Levels of Vitamin D
Dublin, Ireland and Allegan, MI – August 8, 2024 – Perrigo Company plc is issuing a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand. Premium Infant Formula with Iron Milk-Based Powder due to levels of Vitamin D above the maximum level permitted. The recalled product was shipped to H-E-B Grocery Company, LP in TX ; and CVS in the following states: TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO. No other products or retailers are impacted by this recall.
The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing.
Prime Food Processing LLC Issues Allergy Alert on Undeclared Sesame in Steam Buns with Egg Custard Added and Steam Buns with Egg Custard and Coconut Added
Prime Foods Processing LLC of Brooklyn, NY is recalling 477 cases of 2 varieties of Egg Custard Steamed 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 items were distributed in 27 states (AZ, CA, CO, CT, FL, GA, HI, IL, KY, KS, LA, MA, MD, ME, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TX, UT, VA, WA) through Asian grocery stores. These products were distributed between May 30, 2024 and June 28, 2024.
The Prime Foods products being recalled are:
Item #PD4180 Steam Buns with Egg Custard Added Lot Codes #24149, and #24150. Expiration on 10/2025. UPC Code 797803704050
Item #PD4190 Steam Buns with Egg Custard and Coconut Added Lot Codes #24149. Expiration on 10/2025 UPC Code 797803704869
The products are Frozen items packaged in bright yellow packaging. The Code Date information can be found on the bottom of the le side panel.
Thal Golden Spices Inc. Recalls Product Because of Possible Health Risk
Thal Golden Spices Inc. of Hayward, CA is recalling 640 Packs of “Bikano Moong Dal 350g because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product was distributed in the state of California through retail stores.
Product Identification Statement:
Brand Name: Bikano
Product Name: Moong Dal Plain
Size: 350g
Best Used By Date: June 25, 2025 can be found on the bottom back side of the pack.
Too Good Gourmet Issues Allergy Alert on Undeclared Milk in Meijer Dunking Cookies Chocolate Chip 10oz
August 9, 2024 – Too Good Gourmet of San Lorenzo, CA is announcing a recall of Meijer Dunking Cookies Chocolate Chip because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume these products.
The recalled Meijer Dunking Cookies Chocolate Chip were sold at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.
The recalled Meijer Dunking Cookies Chocolate Chip were sold in a 10 oz. tall clear container with a blue and white label, UPC 713733712972. All Best if Used By codes are included in this recall.
Yummy Foods Issues Allergy Alert on Traces of Milk Allergen in Non-Dairy Ices
Yummy Foods, In Edison, NJ is recalling their Yummy Swirly Ices line because it may contain traces of 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.
THIS IS NOT A KASHRUS CONCERN AND THE PRODUCTS ARE ALL CONSIDERED KOSHER PARVE AS CONFIRMED BY THE CRC KASHRUS AGENCY.
The products were distributed through retail supermarkets in New York, New Jersey, Maryland, Ohio, Chicago, Florida, California.
The products are packaged in printed boxes with the Yummy logo and can be found in the freezer aisle in independent kosher supermarkets.
Medical Devices Recalls
Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator
On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).
The devices subject to this correction were manufactured from February 4, 2021 to July 1, 2024, and distributed from February 12, 2021 to July 24, 2024.
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