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
Reason for recall: OOS results reported for the Dissolution (by UV) test.
Recall initiated: 20250515
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated