CIPLA: Drug Recall

Recall #D-0660-2021 · 06/10/2021

Class II: Risk

Recall Details

Recall Number: D-0660-2021
Classification: Class II
Product Type: Drug
Recalling Firm: CIPLA
Status: Terminated
Date Initiated: 06/10/2021
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7228 bottles

Reason for Recall

CGMP Deviations

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.

Distribution Pattern

Nationwide within the United States

Other Recalls by CIPLA

Class II: Risk 09/29/2022

Lack of Assurance of Sterility: environmental monitoring failure.
Class II: Risk 09/15/2022

Lack of Assurance of Sterility
Class II: Risk 08/22/2022

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/22/2022

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/02/2022

Lack of Assurance of Sterility: Complaints received of defective container closure.

View all recalls by CIPLA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.