Food & Beverage Recalls
SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole
July 12, 2024—AB World Foods US, Inc. of Oakbrook Terrace, Illinois, is voluntarily recalling Al’Fez Natural Tahini in 5.6oz glass jars 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.
The recalled Al’Fez Natural Tahini was distributed nationwide in retail stores beginning 05/26/23. The recalled Al’Fez Natural Tahini was sold in 5.6oz glass jars, UPC 711464506778, and with a “BEST BEFORE” of “2024 JL 11” or later. The specific codes being recalled are: Lot Numbers “3031”, “3080”, “3270”, “3297” with corresponding BEST BEFORE: “2024 JL 31”; “2024 SE 09”; “2025 MR 27”; “2025 AL 04”. The recall only applies to these codes, the codes are located on the back of the jar as depicted in the pictures below.
Wiers Farm, Inc Issues a Voluntary Recall on Whole and Salad Cucumbers Due to Possible Contamination with Listeria
Willard, OH (July 12, 2024) - Out of an abundance of caution, Wiers Farm Inc. of Willard, OH, is voluntarily recalling a limited number of whole cucumbers with a pack date of June 5, 2024 and bagged salad cucumbers with a pack date of June 5, 2024 and June 6, 2024 due to possible contamination with Listeria monocytogenes. This product was not grown or harvested by Wiers Farm. It was sourced from out of state, then handled and distributed by Wiers Farm. Wiers Farm Inc. is coordinating closely with regulatory officials in connection with the recall.
The potential contamination was discovered by the Michigan Department of Agriculture and Rural Development (MDARD) through routine sampling.
Dietary Supplements Drugs Recalls
Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton
MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.
The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.
GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients
FOR IMMEDIATE RELEASE – 07/16/2024 – Lilburn, GA, GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone, which are not listed on the label. Products containing acetaminophen, diclofenac and phenylbutazone cannot be marketed as dietary supplements. Infla-650 Herbal Dietary Supplement Capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Use of the product poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.
Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen
FOR IMMEDIATE RELEASE – 7/10/2024 – Atlanta, GA, Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer level. FDA analysis has found these products to be tainted with Sildenafil and acetaminophen. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil in these products renders them an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, those who use nitrates for cardiac conditions are most at risk.
Medical Devices Recalls
Baxter Issues Urgent Medical Device Recall for Volara System Single-Patient Use Circuit
DEERFIELD, Ill., July 15, 2024 – Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly (see Figure 1). The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no injuries reported in association with this issue. Baxter is working with customers to replace the affected products.
When using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is required to help ensure proper operation and ventilator gas flow. If the handset plug disconnects and goes unnoticed prior to or during therapy, it may lead to an interruption or delay of care. This may result in reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter.
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