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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Fesoterodine Fumarate is a medication used to treat overactive bladder symptoms such as urgency and frequency of urination. Consumers typically buy this medication to manage these urinary conditions, often prescribed by healthcare professionals.
The recall involves high levels of a chemical impurity known as 'Diester Impurity,' which can pose health risks if ingested. This impurity exceeds the safety specifications set for the medication and necessitates the recall.
This recall is not part of a broader industry pattern.
Consumers should stop using the medication immediately, which could lead to the need for alternative treatments. The recall may cause inconvenience for those relying on the medication for managing their condition.
You can find the lot number on the bottle label or packaging of the tablets.
Expect a refund or replacement processing time of 4-6 weeks after returning the product.
Document any communications with Alembic Pharmaceuticals and keep copies of receipts or purchases related to the product.
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.
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