Drug product
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
D-0977-2018
Product summary
- Event
- Event 80485
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5215 units
- Official record key
drug-enforcement:D-0977-2018
Official wording
Reason: Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Code information: Lot #: JKS0280A, Exp. 06/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter