FDA-Drug2025-06-04Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
OOS results reported for the Dissolution (by UV) test.
Sold states
Nationwide in the USA
Affected count
8,520 100-count bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2025Don't want to check this manually?
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