The Harvard Drug Group, doing business as Major Pharmaceuticals and Rugby Laboratories, is recalling 3,718 units of Phenytoin Oral Suspension (100 mg/4 mL). This prescription medication, used to control seizures, was distributed in 4 mL unit dose cups. The recall was issued because the product failed content uniformity specifications, which means the amount of medication in each dose may not be consistent. No injuries or incidents have been reported to date.
If the medication does not have a uniform concentration, a patient may receive a dose that is too low or too high. A low dose could lead to a loss of seizure control, while a dose that is too high could result in phenytoin toxicity, which can cause serious health complications.
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Quantity: 3,718 saleable units. Rx only. Distributed by Major Pharmaceuticals Livonia, MI 48152.
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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