Taro Pharmaceuticals U.S.A., the U.S. arm of Israeli-based Taro Pharmaceutical Industries, is recalling certain lots of seizure medication Phenytoin in the form of oral suspension for potential underdosing or overdosing.
The drugmaker is voluntarily recalling two lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Taro found that the recalled lots may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing.
The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention.
Read the company announcement on the FDA site
