Drug Recalls
Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM Sold in 2019 Due to Microbial Contamination Concerns
FOR IMMEDIATE RELEASE – 12/09/2021 – Miami, Florida. Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019. To date, Efficient Laboratories has not received any reports of adverse events.
In rare circumstances, consumption of these specific lots could result in illness. These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency
FOR IMMEDIATE RELEASE –07 December 2021 – Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint.
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
FOR IMMEDIATE RELEASE – December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD) today announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates.
Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping
FOR IMMEDIATE RELEASE – December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.
The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.
Food & Beverage Recalls
Voluntary Recall of Howling Cow Butter Almond Ice Cream Due to Undeclared Soy and Wheat
RESTON, Va. – December 11, 2021 – Maryland & Virginia Milk Producers Cooperative Association (MDVA) announces the immediate recall of one lot of Howling Cow Butter Almond Ice Cream Pints due to undeclared soy and wheat. People who have an allergy or severe sensitivity to soy or wheat run the risk of serious or life-threatening allergic reactions if they consume the Howling Cow Butter Almond Pints.
The recalled pints of Howling Cow Butter Almond Ice Cream are stamped with the SELL BY date of September 15, 2022, which can be found on the bottom of the container, and UPC 0 74336 65079 6.
Bokhary Foods Inc. (d.b.a EKTA Foods) Issues Alert on Undeclared Sulfites in Godavari Dried Apricots
Bokhary Foods Inc. (d.b.a EKTA Foods) of Lawrence, MA is recalling GODAVARI brand dried apricots, because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
GODAVARI brand dried apricots were distributed in Massachusetts, New York, Connecticut through retail stores between 7/10/2021 and 11/24/21. The product comes in 7 oz and 14 oz clear plastic-film bags with the GODAVARI brand label on the front. Each bag is filled with orange-colored dried apricots that can be seen through the bag. The product 7oz product UPC is 0 03658 50001 4 and the 14oz product UPC is 0 03657 5001 5. There is no other coding on the packaging.
Dakota Toms Issues Allergy Alert on Undeclared Egg and Milk in Chicken Salad Croissant
Dakota Toms of Corsica, SD is recalling Chicken Salad Croissant, because it may contain undeclared EGG and MILK allergen. People who have an allergy or severe sensitivity to EGG or MILK allergen run the risk of serious or life-threatening allergic reaction if they consume these products.
Product was distributed in South Dakota, Iowa, Minnesota, and North Dakota to convenient stores and vending machines.
The Chicken Salad Croissants dated 12/7/2021-1/12/2022 located on the front of the package.
BUBS Naturals is Recalling Two Lots of Fountain of Youth Collagen Powder After Firm Testing Found Milk Protein in The Product That Uses MCT Powder Oil as an Ingredient
UPDATED PRESS RELEASE: BUBS Naturals 12/07/2021
**A previous version of this press release issued on December 3, 2021 stated an incorrect recalled lot code. This press release has been updated with the correct recalled lots codes. **
BUBS Naturals of Encinitas, CA is voluntarily recalling certain lots of its Fountain of Youth Formula Collagen Protein (“Fountain of Youth Product”) due to 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 this product
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