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Pharmaceutical Recall Due to Medication Possibly Causing Seizures

Taro Pharmaceuticals U.S., Inc. has issued a voluntary recall for two specific lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles. The two lots included in the recall are numbers: 327874 and 327876, both of which carry an expiration date of December 2020. The medication is used to treat conditions typically found in epileptic patients: grand mal and psychomotor seizures.

The company states it issued the recall because the medication from those specific lots may not re-suspend when shaken, as provided in the instructions. The failure of the medication to re-suspend could result in under or overdosing of the medication. The company’s recall announcement states that the most at-risk population are “infants and young children.” The company warns parents that of infants and young children, there is a “reasonable probability” that inaccurate dosing might result in a “serious adverse effect” such as intoxication or “breakthrough seizures.” A “breakthrough” seizure occurs when an epilepsy patient experiences a sustained period of freedom from seizures, then suddenly experiences a seizure. Breakthrough seizures can be severe, and patients could require hospitalization.

The company further warns for a certain subset of patients, who have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in “life-threatening” status epilepticus that could require immediate emergency treatment. “Status epilepticus” is defined as a continuous seizure lasting more than 30 minutes, or two or more seizures without full recovery of consciousness between any of them.

If you or someone you know has been injured as the result of a product, contact an attorney at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling 713-231-9360 or toll free at 1‑800-594-4884.

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