PlainRecalls
FDA Drug Moderate Class II Terminated

GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21

Reported: March 22, 2017 Initiated: February 3, 2017 #D-0520-2017

Product Description

GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21

Reason for Recall

Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Details

Units Affected
19,393 cartons (581,790 extended release tablets)
Distribution
Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21. Recalled by Amerisource Health Services. Units affected: 19,393 cartons (581,790 extended release tablets).
Why was this product recalled?
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 22, 2017. Severity: Moderate. Recall number: D-0520-2017.