Class II
Terminated
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
This recall has been terminated (originally issued January 22, 2020).
- Recall Initiated
- January 14, 2020
- Posted
- January 22, 2020
- Recall Number
- D-0787-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Cranbury, NJ, United States
- Official Source
- View on FDA website ↗
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
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
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