Drug product
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
D-0953-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0953-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 10212019+53138, Exp 11/19/2020; 10302019+53172, Exp 1/28/2020; 11122019+53225, Exp 2/10/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility