drugs Class II Updated 2012-08-08

VistaPharm, Inc. recalls Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied

Recalled Product

Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50

Hazard / Issue

Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
View official government recall

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