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

FDA recall notice · announced May 1, 2013 · Qualitest Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: C0671212A, Exp 12/14
Quantity: 10,373 bottles
Status: Terminated
Products in this recall event:
- GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21. (D-298-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.