Drug recall
OPANA¿ ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 10 mg, 100 count bottles, Rx Only…
FDA recall event 53318 · Class II · Endo Pharmaceutical, Inc.
Key facts
| Event ID | 53318 |
|---|---|
| Recall numbers | D-024-2010 |
| Recalling firm | Endo Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | OPANA¿ ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 10 mg, 100 count bottles, Rx Only, Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, PA 19317 By: Novartis, Lincoln, NE 68501… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeled; Bottles labeled as 10 mg tablets actually contain 5 mg tablets |
| Initiation date | Sep 16, 2009 |
| Termination date | Sep 14, 2011 |
| City | Westbury |
| State | NY |
| Country | United States |
| FEI number | 3001888307 |
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