FDAFDA · Food and drugs·Recall number D-0787-2020
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
Published January 22, 2020 · Recall initiated: January 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Product was distributed throughout the United States.
- UPC
- 0362756017405
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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