Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #: GG90819, Exp. Date 06/2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- CIPLA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 7228 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-06-10
- FDA classified
- 2021-07-15
- Posted by FDA
- 2021-07-21
- Terminated
- 2024-01-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0660-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.