Recalls / Class II
Class IID-0940-2020
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1990 Westwood Blvd Ste 135, N/A, Los Angeles, California 90025-4650
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Timeline
- Recall initiated
- 2020-01-15
- FDA classified
- 2020-03-05
- Posted by FDA
- 2020-03-11
- Terminated
- 2023-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0940-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.