VistaPharm, Inc. recalls Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-03
Recalled August 8, 2012 · FDA recall D-1440-2012 · VistaPharm
Hazard
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. · FDA Class II
Units
27,221 unit dose cups
Sold at
Nationwide
Description
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.
Product
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →