Drug recall
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60)…
FDA recall event 82092 · Class III · Akorn Inc
Key facts
| Event ID | 82092 |
|---|---|
| Recall numbers | D-0515-2019 |
| Recalling firm | Akorn Inc |
| Product type | Drugs |
| Products | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. |
| Initiation date | Jan 25, 2019 |
| Report date | Feb 27, 2019 |
| Termination date | Nov 3, 2020 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 2315325 |
At a glance
- 1–9 Products in this recall
- None 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: