Drug product
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
D-0333-2025
Product summary
- Event
- Event 96474
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0333-2025
Official wording
Reason: CGMP Deviations
Code information: 30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-25
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations