American Health Packaging recalls GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health…

Recall date

April 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1276-2019

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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