Drug product
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
D-0980-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0980-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 09132019+52914, Exp 2/28/2020; 09162019+52920, Exp 3/2/2020; 09192019+52939; Exp 2/28/2020; 10292019+53162, Exp 4/14/2020; 12112019+53369, Exp 5/27/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility