Taro Pharmaceuticals USA is recalling two lots of Phenytoin Oral Suspension, used for treatment of grand mal and temporal lobe seizures.
Product from these two may not re-suspend when shaken, as instructed for administration, resulting in under or overdosing.
The firm has not received any adverse event reports.
The following lots of the product, packaged in amber plastic bottles with an inner seal and a white child proof closure, with each bottle containing 237 mL, is being recalled:
Each bottle is labeled to indicate the name of the product, Phenytoin Oral Suspension USP, 125 mg/5 mL and the NDC #51672-4069-1
The recalled product was distributed to retail pharmacies for prescription dispensing to patients who were prescribed Phenytoin Oral Suspension.
What to do
Consumers with questions may contact Taro at (866) 705-1553 Monday through Friday between 7:00 am and 7:00 pm (CT), or by e-mail at TaroPVUS@taro.com.