D-0987-2020 Class II Terminated

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

FDA drug recall D-0987-2020 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

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

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

Code Information

Lot #: 08272019+52841, Exp 2/22/2020; 09242019+52953, Exp 3/22/2020; 11072019+53198, Exp 5/5/2020; 11112019+53206, Exp 5/9/2020; 11122019+53223, Exp 5/10/2020