FDA recall D-1050-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2020-01-24

Report date

2020-03-25

Termination date

2020-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1050-2020