Drug recall
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm…
FDA recall event 74794 · Class III · Akorn, Inc.
Key facts
| Event ID | 74794 |
|---|---|
| Recall numbers | D-1469-2016 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point |
| Initiation date | Jul 27, 2016 |
| Report date | Aug 31, 2016 |
| Termination date | Jul 21, 2017 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3003102962 |
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: