Safety alertSource: FDA Drug Enforcement Reports

Class II recall: American Regent, Inc.: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use

American Regent, Inc. issued a Class II recall of Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), for IM or SC use, distributed in 10 mL and 25x10 mL multi-dose vials under NDC 0517-0032-01 and 0517-0032-25. According to the recall notice, the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: Patients receiving vitamin B12 injections for intramuscular or subcutaneous administration who may have received the contaminated American Regent Cyanocobalamin product during the recall period

Read the original at FDA Drug Enforcement Reports

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