Drug product
Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
D-0947-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0947-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 06032019+52353, Exp 7/29/2020; 07082019+52596, Exp 9/2/2020; 10012019+52986, Exp 8/12/2020; 12122019+53374, Exp 1/25/2021
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility