American Regent cyanocobalamin injection recalled for glass particles
American Regent is recalling one lot of Cyanocobalamin Injection, USP, 1000 mcg/mL, in 25 x 1 mL multi-dose vials. The recall notice identifies the particulate matter in the product as glass. The product was distributed nationwide, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All American Regent recalls
What to do
- Set aside affected vials and do not administer them. Affected lot: 24394, expiration date October 31, 2026, NDC 0517-0031-25 (vial NDC 0517-0031-01).
- Contact American Regent, Inc. about the recalled lot. The notice doesn't say how to get a replacement or refund.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY, 11967, NDC 0517-0031-25, (Vial NDC: 0517-0031-01)
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Illnesses reported
- None reported
- Manufactured in
- 5 Ramsay Rd, Shirley, New York, United States
- Classification
- Class II
- Recall number
- D-0172-2027
In the FDA's words
- Description
- Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY, 11967, NDC 0517-0031-25, (Vial NDC: 0517-0031-01) Presence of Particulate matter: Identified as glass Lot #: 24394, Exp. Date October 31, 2026. Distribution: Nationwide within the United States
- Hazard
- Presence of Particulate matter: Identified as glass
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