The drugmaker said product from the affected lots may not re-suspend when shaken as it is supposed to do, which could cause under or overdosing.
Infants and children using the drug are at the most risk, as Taro said there is a reasonable probability that inaccurate dosing could cause serious adverse effects such as intoxication or breakthrough seizures requiring medical intervention.
“For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening status epilepticus requiring immediate emergency room treatment,” Taro said.
Taro said it hasn’t received any adverse event reports related to the recall.
Read the full news release here.
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