Phenytoin Recalled Due to Dosing Concerns

February 21, 2020

Phenytoin is indicated for the treatment of tonic-clonic and psychomotor seizures in pediatric and adult patients.

US FDA

Taro Pharmaceuticals announced that they are voluntarily recalling 2 lots of phenytoin oral suspension 125 mg/5 mL due to dosing concerns.

In a press release, Taro said that the liquid may not re-suspend when shaken, which could result in under- or overdosing of the drug. Phenytoin is indicated for the treatment of tonic-clonic and psychomotor seizures in adult and pediatric patients, though the population at greatest risk for dosing concerns is 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,” the company said. In addition, a change in phenytoin blood levels could trigger status epilepticus in patients who experience severe or repeated breakthrough seizures.

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The 2 lots of concern were distributed to wholesale, long-term care providers, and mail order customers in the US in the spring and summer of 2019. The lots being recalled are: #327874 (Exp: December 2020) and #327876 (Exp: December 2020).

Taro is conducting this recall with the knowledge of the FDA and is currently notifying distributors and retail customers by phone, email, and letters sent via US mail. Any remaining quantities of the drug are to be returned to the wholesaler or manufacturer.

While Taro is not aware of any adverse events related to this recall, the company said that consumers should contact their health care provider if they have experienced any problems that might be related to using phenytoin oral suspension. Any adverse events or issue with quality should be reported to the FDA’s MedWatch Adverse Event Reporting program.

REFERENCE

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5 mL Due to Possible Underdosing or Overdosing [news release]. Hawthorne, NY: Taro Pharmaceuticals. February 20, 2020. businesswire.com/news/home/20200220005975/enAccessed February 21, 2020.