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

FDA recall notice · announced August 8, 2012 · Vistapharm

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Quantity: 27,221 unit dose cups
Status: Terminated
Products in this recall event:
- Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 (D-1440-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.