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
Check against the official notice below — it lists the full affected range.
Sun Pharmaceutical Industries, Inc. is recalling multiple lots of Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL) distributed throughout the United States. The recall affects both 1 mL single-use vials and 10 mL multiple-dose vials due to current good manufacturing practice (cGMP) deviations—specifically, the released lots were manufactured under similar manufacturing conditions to a previously rejected out-of-specification lot. Numerous lot numbers with expiration dates ranging from January 2020 through February 2021 are included in this recall.
The affected lot numbers and expiration dates are listed in the recall details above. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Reason for recall: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. Distribution: Product was distributed throughout the United States. Lot/code info: a) JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, JKT0370A exp Jan-20; JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, JKT0696A, exp Feb-20; JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, JKT1066A exp Mar-20; JKT1149A, JKT1147A, JKT1150A, JKT1427A, JKT1428A, JKT1426A, JKT1429A, JKT1540A, JKT1539A, JKT1541A, JKT1543A, JKT1542A exp Apr-20; JKT1725A, JKT1574A, JKT1727A, JKT1863A, JKT1864A, JKT1865A, JKT1726A exp May-20; JKT2191A exp Jun-20; JKT1866A, JKT2192A, JKT2193A, JKT2194A, JKT2575A, JKT2195A, JKT2576A exp Jul-20; JKT2578A, JKT2579A, JKT2911A, JKT2907A, JKT2908A, JKT2909A, JKT2910A, JKT2577A exp Aug-20; JKT3104A, JKT3105A, JKT3106A, JKT3260A, JKT3261A, JKT3263A, JKT3107A, JKT3467A, JKT3262A, JKT3264A exp Sep-20; JKT3788A, JKT3468A, JKT3749A, JKT3469A, JKT3787A exp Oct-20; JKT3790A, JKT4019A, JKT3789A, JKT4016A, JKT4014A, JKT4017A, Nov-20; JKU0040A exp Dec-20; JKU0041A, JKU0042A, JKU1043A, JKU1044A exp Feb-21; b) JKT1862A, JKT1578A exp May-20; JKT2000A, JKT1999A, JKT2001A exp Jun-20; JKT2593A, JKT2594A exp Jul-20; JKT3863A, JKT4013A exp Nov-20; JKU0037A, JKU0038A, JKU0358A exp Dec-20
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.