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
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