D-0983-2020 Class II Terminated

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

FDA drug recall D-0983-2020 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

Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

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

Code Information

Lot #: 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021