Product: 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 for recall: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Recall initiated: 20220610
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated