Recalls / Class II
Class IID-0943-2020
Product
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1
- Affected lot / code info
- Lot #: 07092019+52610, Exp 2/6/2020; 07232019+52734, Exp 2/19/2020; 08282019+52853, 09042019+52878, 09102019+52903, Exp 3/2/2020; 09182019+52929, Exp 4/17/2020; 10092019+53082, Exp 2/28/2020, 10152019+53124; Exp 5/4/2020; 10222019+53142, Exp 2/28/2020; 10292019+53160, 11052019+53186, Exp 5/4/2020; 11202019+53257, Exp 6/19/2020; 11212019+53270, Exp 6/20/2020; 12042019+53317, Exp 7/3/2020; 12102019+53363, Exp 7/9/2020
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-0943-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.