Drug recall
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by…
FDA recall event 82593 · Class II · American Health Packaging
Key facts
| Event ID | 82593 |
|---|---|
| Recall numbers | D-1276-2019 |
| Recalling firm | American Health Packaging |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero. |
| Initiation date | Apr 8, 2019 |
| Report date | May 8, 2019 |
| Termination date | Nov 6, 2020 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: