Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, ...
FDA Recall #D-1440-2012 — Class II — September 30, 2011
Product Description
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.
Recalling Firm
VistaPharm, Inc. — Largo, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
27,221 unit dose cups
Distribution
Nationwide
Code Information
Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated