FDAFDA · Food and drugs·Recall number D-1276-2019
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
Published May 8, 2019 · Recall initiated: April 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide in the USA
- Lot
- Lot # 181288, EXP 5/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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