Solifenacin Succinate Tablets recalled over manufacturing violations

Recall date

June 10, 2021

Source

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

Official notice title

CIPLA recalls Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufac…

Recall number

D-0660-2021

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations

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, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.