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Class I Recall Issued for Anticonvulsant

March 04, 2020

Taro Pharmaceuticals USA Inc. is recalling two lots of phenytoin oral suspension over concerns the product may coagulate and not resuspend appropriately, according to the March 4, 2020, US Food and Drug Administration (FDA) Enforcement Report. The FDA has designated the recall Class I, suggesting use of the affected product could cause serious adverse health consequences or death. 

The recall affects phenytoin oral suspension, 125 mg/5 mL potency, 8 fluid ounces (237 mL;  NDC 51672-4069-1) from lots 327874 and 327876 (Exp. 12/20). The bottles were distributed throughout the United States. 

Taro Pharmaceuticals voluntarily initiated the recall February 7, 2020. The FDA issued the Class I designation March 2, 2020. 

Phenytoin oral suspension is a prescription anticonvulsant used to prevent and control seizures.

Jolynn Tumolo

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