Drug recall
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals…
FDA recall event 76406 · Class II · Actavis Inc
Key facts
| Event ID | 76406 |
|---|---|
| Recall numbers | D-0476-2017 |
| Recalling firm | Actavis Inc |
| Product type | Drugs |
| Products | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point. |
| Initiation date | Jan 30, 2017 |
| Report date | Feb 22, 2017 |
| Termination date | Mar 13, 2018 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3010259842 |
At a glance
- 1–9 Products in this recall
- 1–9 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: