Drug product
AscorbiX (Buffered C) Injection, Ascorbix (30ML) 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 71283-0226-3
D-0939-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0939-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 07112019+52635, Exp 1/17/2020; 09092019+52890, Exp 3/17/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility