RecallDepth
Class II Terminated

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.

Company
Sun Pharmaceutical Industries Inc
Recall Initiated
June 3, 2022
Posted
June 29, 2022
Recall Number
D-1153-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
97,450 vials
Firm Location
Princeton, NJ, United States

Reason for Recall

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.

Distribution

Nationwide in the USA and Puerto Rico

Lot / Code Info

HAC1974A, HAC1978A, Exp 06/2023

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