Product: Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL  NDC 66689-036-50
Reason for recall: 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.
Recall initiated: 20110930
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated