Drug product
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
D-0583-2025
Product summary
- Event
- Event 97406
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22,656 bottles
- Official record key
drug-enforcement:D-0583-2025
Official wording
Reason: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Code information: Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications