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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Recall Number D-298-2013
Classification Class II
Code Info Lot #: C0671212A, Exp 12/14
Product Distributed Qty 10,373 bottles
Reason For Recall Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Event Detail

Event Id 64960
Product Type Drugs
Status Ongoing
Recalling Firm Qualitest Pharmaceuticals
City Huntsville
State AL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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