drugs Class II Updated 2013-12-18

VistaPharm, Inc. recalls Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case,

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15
View official government recall

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