Solifenacin Succinate Tablets recalled over manufacturing violations

Recall date

January 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Breckenridge Pharmaceutical, Inc recalls Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 519…

Recall number

D-1050-2020

FDA classification

Class II

Brand / firm

Breckenridge Pharmaceutical, Inc

Sold / distributed

Product was distributed nationwide within the United States.

Why it was recalled

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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