Drug Recalls
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.
Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest. The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130. Product was distributed directly from Spectrum facilities nationwide in the USA and to Canada.
Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up
– December 22, 2022 – Durham, North Carolina, Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level.
This product is being recalled because Accord received a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.”
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates
December 22, 2022 - NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Fliptop Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial.
GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
December 23, 2022 – Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the product to be contaminated with Bacillus licheniformis, and Bacillus sonorensis.
Food & Beverage Recalls
Daiso Issues Alergy Alert Tohato and Kashiwado Snacks
Daiso California LLC of La Mirada, CA is recalling the below listed Tohato and Kashiwado snacks due of undeclared allergen ingredients. People who have an allergy or severe sensitivity to almonds, peanuts, soybeans, milk, and shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
Tohato and Kashiwado Snacks were sold in Daiso stores in California, Washington, Nevada, Texas, New York, and New Jersey.
Avery’s Savory Popcorn LLC Issues Allergy Alert on Undeclared Allergens in Gourmet Popcorn
Avery’s Savory Popcorn LLC of Dallas, Texas is recalling Gourmet Popcorn, ALL Flavors because it may contain undeclared specific type of allergen. People who have an allergy or severe sensitivity to specific type of allergen (e.g., milk, soy, peanuts, tree nuts {almonds, walnuts, pecans, cashews}, and sulfites) run the risk of serious or life-threatening allergic reaction if they consume these products.
Gourmet Popcorn, ALL Flavors was distributed in Connecticut, Florida, Georgia, Kentucky, Maryland, Ohio, Oklahoma, Rhode Island, and Texas. The product was shipped direct from the Avery’s Savory Popcorn LLC Online Store. The product was shipped in plastic bags of various sizes without a notice of Undeclared Allergens including (soy, milk, peanuts, tree nuts). Please see the example of the product labeling.
Garden of Light (dba Bakery On Main) Voluntarily Recalls Oat & Honey Organic Granola Due to Potential Almond Contamination
East Hartford, Connecticut December 30th, 2022. Garden of Light (dba Bakery On Main is voluntarily recalling one lot of Organic Oat and Honey Granola for possible Tree nut (Almond)contamination. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.
Product is sold at retailers nationally under the brands:
- Topco/Full circle Organic Oat & Honey Granola with UPC code of 036800420397
- SEG stores under the “Naturally Better” Organic Oats & Honey Granola with UPC code of 07880201130.
The product was produced with a “Best Before Date” (BBD) of 10/10/23. The best before date and UPC code can be found on the back of the film package.
Daiso Issues Allergy Alert on Undeclared Milk in Tohato Nagewa Snack
Daiso California LLC of La Mirada, CA is recalling Tohato Nagewa Snack (skus 4901940112036 & 4901940112005) because it contains an undeclared milk derivative ingredient. 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.
Tohato Nagewa Snack were sold in Daiso stores in California, Washington, Nevada, Texas, Arizona, New York, and New Jersey.
Tohato Nagewa Snack are packaged in a red bag with an image of the crispy potato ring bites on the package. The product is sold in 27g and 73g packages.
SunSprout Enterprises Voluntarily Recalls Two Lots of Alfalfa Sprouts Due to Potential Contamination with Salmonella
Fremont, Nebraska, December 28, 2022 – SunSprout Enterprises is voluntarily recalling two lots (#4211 and 5211) of raw alfalfa sprouts in 4-ounce clamshells, with best by dates between 12/10/22 and 12/27/22, due to potential contamination with Salmonella.
Caesar's Pasta, LLC Recalls Frozen Manicotti Because of Possible Health Risk
Caesar's Pasta, LLC of Blackwood, NJ is recalling 5,610 lbs. of frozen manicotti, because it has the potential to be contaminated with 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.
Frozen manicotti was sold to various foodservice distributors, distributing to restaurants in the Philadelphia, PA; Harrisburg, PA; Southeastern NY State; Northeastern PA; and San Juan, PR markets. Product did NOT enter retail commerce.
Frozen manicotti was packaged in 10 lb. bulk boxes under the brand names Orefresco and Caesar's Pasta with a "Best By" date of September 28, 2024.
Wegmans Food Markets, Inc. Announces Voluntary Recall of Products Containing Micro Greens, Sweet Pea Leaves, and Cat Grass Because of Possible Health Risk
ROCHESTER, NY - Wegmans Food Markets, Inc. is issuing a voluntarily recall on its products containing micro greens, sweet pea leaves, and cat grass because they have 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 affected products were sold at various Wegmans stores in NY, PA, MA, NJ, VA, MD & NC. A full list of potentially affected items can be found on the recall page of Wegmans.com.
World Variety Produce, Inc. Voluntarily Recalls Melissa’s Pasta Para Duros 12oz Because it Contains Undeclared Wheat Allergens
People with an allergy or severe sensitivity to Wheat run the risk of serious or life-threatening allergic reaction if they consume this product. The product was sold in the produce department and distributed in the states of Illinois, Indiana, Kentucky, Michigan, Ohio, Wisconsin.
Medical Device Recalls
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps
MINNEAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or under delivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.
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