Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Recall Number: D-1153-2022

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Terminated

Report Date: 20220629

Initiation Date: 20220603

Termination Date: 20230524

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.