Alembic Pharmaceuticals Limited recalled Fesoterodine Fumarate, Extended-release Tablets after discovering high levels of a harmful impurity. The recall affects approximately 30,000 tablets distributed nationwide. Consumers must stop using the medication immediately and consult their healthcare providers.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Consumers and healthcare providers should stop using this product immediately. Contact Alembic Pharmaceuticals Limited or your healthcare provider for guidance
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The recall involves Fesoterodine Fumarate, Extended-release Tablets, 8 mg, sold in 30-tablet bottles. The affected lot number is 2405003360, with an expiration date of January 31, 2026. Products were manufactured in Gujarat, India, and distributed across the U.S. and Puerto Rico.
The recall stems from the detection of 'Diester Impurity' levels exceeding acceptable limits. This impurity poses health risks and has prompted the company to classify the recall as Class III.
There are no reported injuries or adverse health effects associated with this recall. The recall was initiated as a precautionary measure due to the impurity levels.
Consumers must stop using Fesoterodine Fumarate tablets immediately. For guidance, contact Alembic Pharmaceuticals Limited or consult your healthcare provider.
For questions, consumers may reach Alembic Pharmaceuticals Limited at their contact number or visit their website for more information.
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