VistaPharm, Inc. recalls Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: Vist

Recalled December 18, 2013 · FDA recall D-342-2014 · VistaPharm

Hazard

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

Units

27,788 cases

Sold at

Nationwide and Puerto Rico

Description

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

Product

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

Manufacturer(s)

VistaPharm, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →