Drug recall D-0787-2020
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
Reason for recall
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Lots and codes
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 details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 14, 2020
- Terminated
- August 31, 2020
Related products
- Testosterone Cypionate – drug information
- NDC 62756-015 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-016 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-017 Testosterone Cypionate · Testosterone Cypionate 100 mg/mL · Sun Pharmaceutical Industries, Inc.