FDA-Drug2017-03-22Class II

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

Amerisource Health Services
Hazard

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

Sold states
Nationwide
Affected count
19,393 cartons (581,790 extended release tablets)
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2017

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