Glenmark Pharmaceuticals Inc. USA recalls theophylline extended-release 400 mg tablets after dissolution test failures. The recall covers 22,656 bottles distributed nationwide in the United States. Consumers should stop using the product and contact Glenmark for guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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Theophylline extended-release tablets are used to treat certain respiratory conditions by maintaining steady theophylline levels in the body.
Dissolution failures may lead to inconsistent drug release, potentially affecting therapeutic effectiveness.
This recall is not identified as part of a broader industry pattern in the provided data.
Consumers may experience reduced or inconsistent medication effectiveness, requiring clinician guidance.
NDC on the bottle label and packaging; recall page for enforcement details
Refund or replacement processing timelines are not specified in the data; contact manufacturer for guidance
Keep bottle, UPCs, label, batch numbers, and recall notice for records
Brand: Glenmark Pharmaceuticals Inc. USA. Product: Theophylline extended-release tablets 400 mg, Rx only. NDC: 68462-380-01. Form: 100-count bottle. Batch numbers include 19243193, 19243215, 19243231, 19243248, 19243283, 19244530, 19244561, 19250178. Manufactured by Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, India. Distributed nationwide in the USA. Recall date: 2025-08-08. Status: Active. Quantity: 22,656 bottles.
No specific injuries or incidents are reported in the provided data.
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