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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65756
Product Type Drugs
Status Ongoing
Recalling Firm VistaPharm, Inc.
City Largo
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-04
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13. Class II Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. 1,707,050 cups / 5ml ea. D-913-2013