Major Pharmaceuticals recalls Phenytoin Oral Suspension due to failed content uniformity specifications. This may affect medication dosing accuracy. Contact for remedy details.
Failed Content Uniformity Specifications
Major Pharmaceuticals is recalling Phenytoin Oral Suspension (100 mg/4 mL) because it failed content uniformity tests. This could lead to incorrect medication dosing, which is serious for patients using this anticonvulsant.
The medication may not contain the correct amount of active ingredient per dose. This could result in under-dosing, which might not control seizures effectively, or over-dosing, which could cause adverse effects.
Patients prescribed Phenytoin Oral Suspension by a doctor are affected. Those with seizure disorders or other conditions requiring this medication are most at risk.
Check for the product name 'Phenytoin Oral Suspension, USP, 100 mg/4 mL' in 4 mL unit dose cups. Look for lot numbers C00099, C00115 (expiring 07/31/2024) or C00079 (expiring 12/31/2023).
Verify the lot number and expiration date on the packaging to confirm if it's in the recalled batch.
The recall is due to failed content uniformity specifications, which could affect dosing accuracy. It is not safe to use without checking the recall status.
Look for the product name 'Phenytoin Oral Suspension, USP, 100 mg/4 mL' in 4 mL unit dose cups with lot numbers C00099, C00115 (expiring 07/31/2024) or C00079 (expiring 12/31/2023).
The recall record does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0153-2024 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0153-2024 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
