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 0517-0031-01), and b) 25x1 mL Mu
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- Company / brand
- American Regent, Inc.
- Product
- Cyanocobalamin 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 / hazard
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-07-24
- Code info
- Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
- Product quantity
- 235,350 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- NY
- Country
- United States
- Event id
- 99503
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