Amneal Pharmaceuticals is recalling 9,263 bottles of Extended Phenytoin Sodium Capsules, USP (100 mg), a medication used to control certain types of seizures. The recall was issued because the product failed dissolution testing, meaning the capsules might not dissolve at the correct rate to release the medication into the body as intended. Consumers should speak with their healthcare provider or pharmacist regarding their medication and potential treatment alternatives.
If the capsules do not dissolve correctly, the medication may not be released at the proper rate, which can lead to inconsistent drug levels in the bloodstream. This could potentially reduce the drug's effectiveness in preventing seizures. No incidents or injuries have been reported to date.
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Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ, 08807.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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