Reported Jan 22, 2020 · Terminated
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…
Sun Pharmaceutical Industries, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- 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 bySun Pharmaceuticals, Inc., Cranbury, NJ
- Manufactured bySun Pharmaceuticals, Industries, Ltd., Gujarat, India
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, JKT0370A exp Jan-20 2 JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, JKT0696A, exp Feb-20 3 JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, JKT1066A exp Mar-20 4 JKT1149A, JKT1147A, JKT1150A, JKT1427A, JKT1428A, JKT1426A, JKT1429A, JKT1540A, JKT1539A, JKT1541A, JKT1543A, JKT1542A exp Apr-20 5 JKT1725A, JKT1574A, JKT1727A, JKT1863A, JKT1864A, JKT1865A, JKT1726A exp May-20 6 JKT2191A exp Jun-20 7 JKT1866A, JKT2192A, JKT2193A, JKT2194A, JKT2575A, JKT2195A, JKT2576A exp Jul-20 8 JKT2578A, JKT2579A, JKT2911A, JKT2907A, JKT2908A, JKT2909A, JKT2910A, JKT2577A exp Aug-20 9 JKT3104A, JKT3105A, JKT3106A, JKT3260A, JKT3261A, JKT3263A, JKT3107A, JKT3467A, JKT3262A, JKT3264A exp Sep-20 10 JKT3788A, JKT3468A, JKT3749A, JKT3469A, JKT3787A exp Oct-20 11 JKT3790A, JKT4019A, JKT3789A, JKT4016A, JKT4014A, JKT4017A, Nov-20 12 JKU0040A exp Dec-20 13 JKU0041A, JKU0042A, JKU1043A, JKU1044A exp Feb-21 14 JKT1862A, JKT1578A exp May-20 15 JKT2000A, JKT1999A, JKT2001A exp Jun-20 16 JKT2593A, JKT2594A exp Jul-20 17 JKT3863A, JKT4013A exp Nov-20 18 JKU0037A, JKU0038A, JKU0358A exp Dec-20
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
This product could cause temporary or reversible health problems — stop using it.
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