Seizure medicine for infants and children recalled. It can cause dangerous seizures
Two lots of Phenytoin Oral Suspension 125mg/5mL infants and children’s seizure medicine have been recalled for a problem that can cause overdosing or underdosing.
According to the FDA-posted recall notice written by manufacturer Taro Pharmaceuticals, “product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing.”
As for the potential consequences of that, “there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention.”
What Taro referred to as “a small minority of patients” who get longer seizures or a series of seizures with no recovery time (known as “status epilepticus”) might need a life-saving trip to the emergency room.
This covers lot Nos. 327874 and 327876 in 237mL bottles, distributed between May 3 to July 5, 2019 and July 1 to Aug. 21, 2019, respectively. Both lots have the December 2020 expiration date.
Consumers who have any of these two lots should stop using them and see their healthcare provider about replacement or alternative treatment. Those with questions can email Taro at TaroPVUS@taro.com or call Taro at 866-705-1553, Monday through Friday, 8 a.m. to 8 p.m., Eastern time.
To report any bad reactions or quality complaints from taking this or any drug, contact the FDA’s MedWatch Adverse Event Reporting program by clicking here or calling 80-332-1088 to ask for a reporting form to send by mail or fax.
This story was originally published February 23, 2020 at 9:03 AM with the headline "Seizure medicine for infants and children recalled. It can cause dangerous seizures."
