D-0452-2025 Class II Ongoing
FDA drug recall D-0452-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on May 15, 2025 and is designated Class II. Reason for recall: OOS results reported for the Dissolution (by UV) test. The recall status is ongoing. Affected quantity: 8,520 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 4, 2025
- Initiation Date
- May 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,520 100-count bottles
Product Description
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
Reason for Recall
OOS results reported for the Dissolution (by UV) test.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26