Product: Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India
Reason for recall: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Recall initiated: 20200114
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated