Recalls / Class II
Class IID-0945-2020
Product
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
- Affected lot / code info
- Lot #: 11132019+53229, Exp 2/10/2020
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-0945-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.