Drug Enforcement D-298-2013

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Status

Terminated

Classification

Class II

Report Date

May 1, 2013

Termination Date

January 13, 2014

Product Information

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.
Product quantity
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Qualitest Pharmaceuticals
Address
120 Vintage Dr NE

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-298-2013
Event ID
64960
Recall initiation date
April 19, 2013
Center classification date
April 25, 2013
Code info
Lot #: C0671212A, Exp 12/14
More code info
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