Sun Pharmaceutical Industries, Inc. recalls 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 m
Recalled January 22, 2020 · FDA recall D-0788-2020 · Sun Pharmaceutical Industries
Hazard
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. · FDA Class II
Sold at
Product was distributed throughout the United States.
Description
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
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
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →