FDA recall D-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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-19

Report date

2013-05-01

Termination date

2014-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-298-2013