Drug product
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
D-0660-2021
Product summary
- Firm
- CIPLA
- Event
- Event 88090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7228 bottles
- Official record key
drug-enforcement:D-0660-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #: GG90819, Exp. Date 06/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations