drugs Class II Updated 2012-08-29

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

Recalled Product

Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50

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 202800, NDC 66689-035-50
View official government recall

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