Drug product
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
D-1051-2020
Product summary
- Event
- Event 85186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11, 250 bottles
- Official record key
drug-enforcement:D-1051-2020
Official wording
Reason: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Code information: Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Distribution pattern: Product was distributed nationwide within the United States.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations