Product: Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), 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