Drugs and Dietary Supplement Recalls
Alcon Laboratories recalls Systane Lubricant Eye Drugs
FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.
Risk Statement: Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients. To date, Alcon Laboratories has not received any reports of adverse events related to this recall.
Astellas Pharma US, Inc. recalls Astellas Tacrolimus and Tacrolimus Extended-Release capsules
FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.
Risk Statement- transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal. To date, Astellas has not received any reports of adverse events related to this recall.
Endo, Inc. recalls Par Pharmaceutical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
MALVERN, PA, December 20, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-dates the 1938 Federal Food, Drug & Cosmetic Act, was never submitted for approval by the FDA, and as such, is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. In addition, FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by Endo USA, Inc.
Both products are distributed to hospitals and healthcare systems for use by healthcare professionals. The similarity in labeling makes it difficult to distinguish between the non-sterile topical and sterile injectable product which can lead to potential administration errors. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial.
Shoppers-Plaza recalls Fouzee SugarL in Herbal Formula Herbal Dietary Supplement
FOR IMMEDIATE RELEASE – December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See Attachment 1 for photo of product labeling. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Metformin is the active ingredient in several FDA-approved prescription drugs used to treat type 2 diabetes and is only available with a prescription. Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated. Symptoms of lactic acidosis include nausea, vomiting, fatigue, body aches, respiratory distress, abdominal pain and fast, deep breathing. Metformin may also cause hypoglycemia when taken together with other medications to lower blood sugar.
Food and Beverage Recalls
Frito-Lay recalls Lay’s Potato Chip
PLANO, Texas – December 16, 2024 – Frito-Lay today issued a recall of a limited number of 13 oz. bags of Lay’s Classic Potato Chips that may contain undeclared milk, after being alerted through a consumer contact. Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the recalled product.
The product included in this recall was distributed to certain retail stores and e-commerce distributors in Oregon and Washington. Consumers would have been able to purchase these chips as early as November 3, 2024.
Jose Madrid Salsa recalls Jose Madrid Chipotle Con Queso Salsa
Recall of Jose Madrid Salsa Chipotle Con Queso
Jose Madrid Salsa is announcing a voluntary recall of our Chipotle Con Queso Salsa. The salsa is being recalled because it contains Yellow 5 and Yellow 6, which were not listed on the ingredient label. Individuals who are allergic or sensitive to Yellow 5 or Yellow 6 run the risk of minor to serious or life-threatening allergic reactions if they consume this product.
The product was sold at the following events in NY and NC:
Christmas in the Country event in Hamburg, NY November 7-10, 2024.
Syracuse Holiday Shoppes event in Syracuse, NY November 8-10, 2024.
Greensboro Holiday Market event in Greensboro, NC November 15-17, 2024.
The recalled Jose Madrid Chipotle Con Queso Salsa, Net Wt. 13 oz., with UPC: 093662452935, is packaged in a Glass container. The lot codes, stamped on the top of the jar are:
6012201
102327
6012201
103027
6012201
111227
No Illnesses have been reported to date.
Lidl US recalls Taste of Deutschland Frozen Buttered Vegetables, Carrots, Peas, Cauliflower, & Corn
Lidl Recalls Taste of Deutschland Buttered Vegetables Due to Undeclared Milk Allergens
ARLINGTON, VA – DECEMBER 20, 2024 – Lidl US is recalling all lots of their Taste of Deutschland Buttered Vegetables 10.5 oz box UPC 4 056489 122876 due to undeclared milk allergen. The recall was issued due to undeclared milk in the products. People who have allergies to milk run the risk of serious or life-threatening allergic reactions if they consume these products.
Lidl US has received no reports or complaints of illness related to this product to date.
The recall was initiated after it was discovered by the FDA during an inspection that the labels did not list the allergen milk in the ingredient statement.
Orgain recalls 30g Plant Protein Complete Protein Powder – Chocolate
Orgain of Irvine, California is voluntarily recalling a single batch of its 30g Protein Organic Plant Based Powder - Chocolate 2.01lb because it may contain undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts may run the risk of serious or life-threatening allergic reaction if they consume this product.
The recall is limited to a single batch of 30g Protein Organic Plant Based Powder - Chocolate 2.01lb and was distributed nationwide both in retail stores and online. The product comes in a 2.01lb plastic tub with a blue label indicating its chocolate flavor and has an expiration date of June 20, 2026. The product lot code is 4172-02-P.
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