X-Gen Pharmaceuticals Inc. is recalling 25,120 vials of Levetiracetam Injection, 500 mg/5mL, a prescription medication used to treat seizures. This voluntary recall was initiated because the product was distributed with an incorrect version of the package insert. Because the package insert contains critical dosing and safety information, an incorrect version could lead to improper use of the medication.
The use of an incorrect package insert may result in healthcare providers or patients receiving outdated or incorrect instructions for administration, dosing, or safety warnings, which could lead to ineffective treatment or adverse health consequences.
Refund or Guidance
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Sources: FDA iRES · Raw API Response
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