FDA recall D-0660-2021

Product

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.

Reason for recall

CGMP Deviations

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-06-10

Report date

2021-07-21

Termination date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2021