Recall Enforcement Report D-0787-2020

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0787-2020	01-14-2020	01-22-2020	Class II		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	cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.	Terminated
D-0788-2020	01-14-2020	01-22-2020	Class II		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	cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.	Terminated

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
62756-015	Testosterone Cypionate	Testosterone Cypionate	Injection, Solution	Intramuscular	Sun Pharmaceutical Industries, Inc.	Human Prescription Drug
62756-016	Testosterone Cypionate	Testosterone Cypionate	Injection, Solution	Intramuscular	Sun Pharmaceutical Industries, Inc.	Human Prescription Drug
62756-017	Testosterone Cypionate	Testosterone Cypionate	Injection, Solution	Intramuscular	Sun Pharmaceutical Industries, Inc.	Human Prescription Drug

D-0788-2020

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Product was distributed throughout the United States.

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

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Voluntary: Firm initiated

01-22-2020

01-14-2020

08-31-2020

Letter

Drugs

Sun Pharmaceutical Industries, Inc.

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

62756-017-40; 62756-015-40; 62756-016-40

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recall Enforment Report D-0787-2020

Recall Details

Recall Enforcement Reports

Recalled Products