PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: July 21, 2021 Initiated: June 10, 2021 #D-0660-2021

Product Description

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

Details

Recalling Firm
CIPLA
Units Affected
7228 bottles
Distribution
Nationwide within the United States
Location
Warren, NJ

Frequently Asked Questions

What product 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.. Recalled by CIPLA. Units affected: 7228 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on July 21, 2021. Severity: Moderate. Recall number: D-0660-2021.