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.
- 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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