Recalls / Class II
Class IID-1051-2020
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
- Affected lot / code info
- Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Why it was recalled
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 11, 250 bottles
- Distribution pattern
- Product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2020-01-24
- FDA classified
- 2020-03-23
- Posted by FDA
- 2020-03-25
- Terminated
- 2020-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1051-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.