FDAApril 8, 2019drug

GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

What to do

FDA enforcement status: Terminated

Brands named

american health packagingamericanamerican health

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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