Class II
Ongoing
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
This recall is currently active, issued June 4, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- May 15, 2025
- Posted
- June 4, 2025
- Recall Number
- D-0452-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,520 100-count bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
OOS results reported for the Dissolution (by UV) test.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
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