D-0942-2020 Class II Terminated

Recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical — Los Angeles, CA

FDA drug recall D-0942-2020 was initiated by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical on January 15, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated December 7, 2023). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
March 11, 2020
Initiation Date
January 15, 2020
Termination Date
December 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

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

Code Information

Lot #: 10022019+53004, Exp 2/28/2020; 11252019+53282, Exp 6/12/2020