Drug product
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
D-0949-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0949-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 09252019+52967, Exp 4/4/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility