Drug product
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
D-0766-2022
Product summary
- Event
- Event 89941
- Status
- Terminated
- Classification
- Class III
- Quantity
- 433,809 vials
- Official record key
drug-enforcement:D-0766-2022
Official wording
Reason: Subpotent Drug: Out of Specification results for Assay
Code information: Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent