FDA-Drug2025-08-20Class II
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Sold states
USA nationwide.
Affected count
22,656 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0583-2025Don't want to check this manually?
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