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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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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

Product Detail

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