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American Regent, Inc.: Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-003…

SourceFDA · Drugs (US)
Date2026-08-26
ProductCyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Reason / hazardPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
ClassificationClass II
Official notice
Record IDfda-drug:D-0792-2026

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