Class II
Terminated
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) 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
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- January 24, 2020
- Posted
- March 25, 2020
- Recall Number
- D-1050-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,250 bottles
- Firm Location
- Berlin, CT, United States
Reason for Recall
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Distribution
Product was distributed nationwide within the United States.
Lot / Code Info
Lot #: a) 81244, 81217, Exp. Date 01/2021 and b) 81245, Exp. Date 01/2021
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