American Health Packaging cyanocobalamin recalled for possible glass
American Regent notified BluePoint Laboratories of potential glass particle contamination in a batch of cyanocobalamin injection, USP, 1,000 mcg/mL, sold in 25-vial cartons. The recall covers lot 24394A, expiration 10-31-2026, with about 4,097 cartons distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All American Health Packaging recalls
What to do
- Set aside any cartons from lot 24394A and do not administer them.
- Check the carton NDC 68001-542-60 and vial NDC 68001-542-59, along with lot 24394A and expiration 10-31-2026, to identify affected product.
- The notice does not specify a remedy; contact American Health Packaging or BluePoint Laboratories for return or replacement instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cyanocobalamin Injection, USP, 1,000 mcg/mL, Rx Only, 25 x 1mL -Multiple-Dose Vials per carton, Mfg. by: American Regent, Inc., For Bluepoint Laboratories. Carton NDC 68001-542-60; Vial NDC 68001-542-59
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 4,097- cartons (25 x 1mL vials)
- Illnesses reported
- None reported
- Manufactured in
- 2550 John Glenn Ave Ste A, Columbus, Ohio, United States
- Classification
- Class II
- Recall number
- D-0173-2027
In the FDA's words
- Description
- Cyanocobalamin Injection, USP, 1,000 mcg/mL, Rx Only, 25 x 1mL -Multiple-Dose Vials per carton, Mfg. by: American Regent, Inc., For Bluepoint Laboratories. Carton NDC 68001-542-60; Vial NDC 68001-542-59 Presence of particulate matter:American Regent, Inc. notified BluePoint Pharmaceuticals Laboratories regarding potential glass particle contamination (foreign glass fragment) identified in the product batch. Lot: 24394A, Exp 10-31-2026 Distribution: Nationwide in the USA Affected quantity: 4,097- cartons (25 x 1mL vials)
- Hazard
- Presence of particulate matter:American Regent, Inc. notified BluePoint Pharmaceuticals Laboratories regarding potential glass particle contamination (foreign glass fragment) identified in the product batch.
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