FDA · Drug recall

Testosterone Cypionate for Injection… and 1 more product

Jan. 22, 2020 Class II

Date: Jan. 22, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): 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)
Status: Terminated
Filed by: Sun Pharmaceutical Industries, Inc.
Reason: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Distribution pattern: Product was distributed throughout the United States.

2 products in this recall

Testosterone Cypionate for Injection…

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
Codes and lots: JKT0933A, JKT0935A, JKT1062A exp Mar-20; JKT1425A, JKT1483A exp Apr-20; JKT1575A, JKT1729A, JKT1730A, JKT1728A exp May-20 JKT2002A exp Jun-20; JKT3216A, JKT3217A exp Sep-20; JKT3589A, JKT3590A, JKT3626A exp Oct-20; JKT3864A, JKT3935A exp Dec-20
Recall started: Jan. 14, 2020
Recall number: D-0787-2020

Testosterone Cypionate for Injection…

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
Codes and lots: 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
Recall started: Jan. 14, 2020
Recall number: D-0788-2020

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement reports, recall numbers D-0787-2020, D-0788-2020. The agency record governs; check it and the company before acting.

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