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
Reported: June 4, 2025 Initiated: May 15, 2025 #D-0452-2025
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.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 8,520 100-count bottles
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 8,520 100-count bottles.
Why was this product recalled? ▼
OOS results reported for the Dissolution (by UV) test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 4, 2025. Severity: Moderate. Recall number: D-0452-2025.
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