Amneal Pharmaceuticals is recalling approximately 12,584 vials of Fosphenytoin Sodium Injection, USP (500 mg PE/10 mL) because visible solid particles were found in the medication. This injectable drug is used to treat and prevent seizures. Injecting a solution containing foreign particles can lead to serious health issues, including inflammation of the veins or blockage of blood vessels. Consumers and healthcare providers can identify the affected products by checking for NDC 70121-1390-1 and the specific lot numbers and expiration dates listed below.
The presence of particulate matter in an injectable drug poses a serious risk because the particles can travel through the bloodstream and lodge in vital organs. This could cause inflammation, local irritation, or an embolism (blockage of a blood vessel), which may lead to stroke or other life-threatening complications.
Refund for unused vials of the medication.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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