Drug 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

D-0943-2020

January 15, 2020

Class II

Product summary

Firm: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Event: Event 84978
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0943-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 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

Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility