Drug Safety Alerts

Taro Phenytoin Oral Suspension Consumer-Level Recall

2/21/2020

On February 21, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Phenytoin Oral Suspension USP, 125 mg/5 mL NDC # 51672-4069-01 manufactured by Taro Pharmaceuticals, U.S.A., Inc. (Taro).This recall was issued because product may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

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. 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. In its announcement of the recall, Taro advised that it has not received any adverse event reports related to this recall.

This recall affects lot numbers 327874 exp. 12/20 and 327876 exp. 12/20. Patients who have been using affected product have been instructed to call their healthcare provider immediately.

Lot 327874 was distributed to wholesale distributors, long-term care providers, a repackager and mail order customers in the U.S. market between May 3 and July 5, 2019. Lot 327876 was distributed to wholesale distributors, long-term care providers and mail order customers in the U.S. market between July 1 and August 21, 2019. These customers may have further distributed these lots to retail pharmacies for prescription dispensing to patients who were prescribed Phenytoin Oral Suspension.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Phenytoin Oral Suspension USP, 125 mg/5 mL manufactured by Taro to contact their prescriber.

For more information about this recall, please contact Taro Pharmaceuticals at 1-866-705-1553, Monday through Friday, 7:00 am through 7:00 pm (CT), email at TaroPVUS@taro.com or visit https://taro.gcs-web.com.

You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.