Drug product
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
D-0452-2025
Product summary
- Event
- Event 96867
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,520 100-count bottles
- Official record key
drug-enforcement:D-0452-2025
Official wording
Reason: OOS results reported for the Dissolution (by UV) test.
Code information: Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
OOS results reported for the Dissolution (by UV) test.