Drug product
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
D-1125-2019
Product summary
- Event
- Event 82463
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75968 vials
- Official record key
drug-enforcement:D-1125-2019
Official wording
Reason: Presence of Particulate Matter.
Code information: Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter