Sun Pharmaceutical Industries, Inc.: 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, I

Is my product affected?

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

• Brand TESTOSTERONE CYPIONATE

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceutical Industries, Inc. is recalling multiple lots of Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL vials distributed throughout the United States. The recall was initiated due to current good manufacturing practice (cGMP) deviations, specifically because the released lots were manufactured under similar manufacturing conditions to a previously rejected out-of-specification lot.

The affected lots include: JKT0933A, JKT0935A, and JKT1062A (expiring March 2020); JKT1425A and JKT1483A (April 2020); JKT1575A, JKT1729A, JKT1730A, and JKT1728A (May 2020); JKT2002A (June 2020); JKT3216A and JKT3217A (September 2020); JKT3589A, JKT3590A, and JKT3626A (October 2020); and JKT3864A and JKT3935A (December 2020). The source does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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