D-1051-2020 Class II Terminated
FDA drug recall D-1051-2020 was initiated by Breckenridge Pharmaceutical, Inc on January 24, 2020 and is designated Class II. Reason for recall: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. The recall status is terminated (terminated October 19, 2020). Affected quantity: 11, 250 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- January 24, 2020
- Termination Date
- October 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11, 250 bottles
Product Description
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
Reason for Recall
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Distribution Pattern
Product was distributed nationwide within the United States.
Code Information
Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021