Recall D-0452-2025

US Class II Ongoing · initiated 2025-05-15

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

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.

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