FDA Recall Terminated Historical recordClass II
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.
- Reason
- 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.
- Published
- June 29, 2022
- Distribution
- Nationwide
