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.
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