Par Pharmaceutical recalled 1,041 cartons of Everolimus tablets on September 5, 2025. The recall stems from failed impurities and degradation specifications. Consumers should stop using the product immediately.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Consumers and healthcare providers should stop using this product immediately. Contact Endo USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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The recall includes Everolimus tablets 5mg, packaged in cartons containing four blister strips of seven tablets each. The affected lot number is 550172301, with an expiration date of January 2026. The product was distributed nationwide.
The tablets failed to meet impurities and degradation specifications, specifically for impurity IP-C. This poses a potential health risk to consumers, leading to the recall classification as Class III.
There are no reported incidents of injury or adverse effects associated with the recalled product at this time. However, the potential health risks warrant immediate action.
Consumers and healthcare providers should stop using Everolimus tablets immediately. Contact Endo USA, Inc. for guidance on the recall. Notifications will be sent via letter.
For further assistance, call Endo USA, Inc. at 1-XXX-XXX-XXXX or visit their website at www.endo.com.
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