Recalls / Class II
Class IID-0973-2020
Product
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
- Affected lot / code info
- Lot #: 07102019+52618, Exp 2/8/2020; 09052019+52880, Exp 4/5/2020; 10012019+52983, Exp 5/1/2020; 11052019+53188, Exp 6/5/2020; 12112019+53367, Exp 7/11/2020
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-0973-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.