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Drug Recalls

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A drug recall is one of the most effective ways to protect consumers from a defective or potentially harmful medicine. A recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.

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Drug Recall Announcements by Company



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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt
Fresenius Kabi Tyenne Injection 400 mg/20 mL vial Due to Presence of Glass Particles Fresenius Kabi
Fresenius Kabi Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL Due to a label mix-up Fresenius Kabi
VMC Compounded Glutathione 200 mg/mL Multi-Dose Vials Elevated Endotoxin level Victory Medical Center Pharmacy
OPTIRAY OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml) Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass Liebel-Flarsheim Company, LLC
American Regent, Inc. Animal Health Adequan Canine Injection and Adequan i.m Injection for horses Visible glass fiber material in the product American Regent, Inc. Animal Health
American Regent, Inc. Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Products were found to contain particulate matter American Regent, Inc.
Long Grove Pharmaceuticals Cyclophosphamide for Injection Presence of particulate matter identified as steel Sunny Pharmtech, Inc.
Baxter Cefazolin in Dextrose Injection Particulate matter (cardboard) found in the solution. Baxter International Inc.
Rising Pharma Holdings Inc. Cetirizine Hydrochloride Tablets USP 5 mg Potential cross contamination with Ranitidine Unique Pharmaceutical Laboratories
Beekeeper’s Naturals Saline Nasal Spray Above acceptable microbiological limits for yeast and may contain Aspergillus spp. Beekeeper’s Naturals
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