Drug product
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
D-0940-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0940-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 08222019+52828, Exp 2/28/2020; 09092019+52889, Exp 3/17/2020; 09182019+52924, Exp 3/26/2020; 09262019+52971, Exp 4/3/2020; 10142019+53108, Exp 4/21/2020; 10212019+53136, Exp 4/28/2020; 10302019+53164, Exp 5/7/2020; 11252019+53278, Exp 6/2/2020; 11262019+53284, Exp 6/3/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility