Recalls / Class II

Class IID-298-2013

Product

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.

Affected lot / code info

Lot #: C0671212A, Exp 12/14

Why it was recalled

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

Recalling firm

Firm

Qualitest Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

120 Vintage Dr NE, Huntsville, Alabama 35811-8216

Distribution

Quantity

10,373 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-04-19

FDA classified

2013-04-25

Posted by FDA

2013-05-01

Terminated

2014-01-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-298-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.