Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

Recall Number: D-342-2014

Firm: VistaPharm, Inc.

Classification: Class II

Status: Terminated

Report Date: 20131218

Initiation Date: 20131015

Termination Date: 20160928

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50