Drug recall
Actavis Fentanyl Transdermal System 25 mcg/h strength, Rx; NDC 67767-120-18; distributed by Actavis South…
FDA recall event 57003 · Class I · Actavis South Atlantic LLC
Key facts
| Event ID | 57003 |
|---|---|
| Recall numbers | D-426-2011 |
| Recalling firm | Actavis South Atlantic LLC |
| Product type | Drugs |
| Products | Actavis Fentanyl Transdermal System 25 mcg/h strength, Rx; NDC 67767-120-18; distributed by Actavis South Atlantic LLC, 13800 N W 2nd Street, Suite 190, Sunrise, FL 33325 USA; Manufactured by: Corium… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Exceeds Dissolution Specification: high dissolution results were obtained during testing |
| Initiation date | Oct 15, 2010 |
| Termination date | Sep 20, 2012 |
| City | Sunrise |
| State | FL |
| Country | United States |
| FEI number | 3004090892 |
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