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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, 50 unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Recall Number D-1440-2012
Classification Class II
Code Info Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Product Distributed Qty 27,221 unit dose cups
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.

Event Detail

Event Id 62421
Product Type Drugs
Status Ongoing
Recalling Firm VistaPharm, Inc.
City Largo
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide