Drug recall
DIFLORASONE DIACETATE CREAM, USP, 0.05%, 15 grams per tube (NDC 0168-0242-15) and 30 grams per tube (NDC…
FDA recall event 55285 · Class II · Nycomed US, Inc.
Key facts
| Event ID | 55285 |
|---|---|
| Recall numbers | D-515-2010 |
| Recalling firm | Nycomed US, Inc. |
| Product type | Drugs |
| Products | DIFLORASONE DIACETATE CREAM, USP, 0.05%, 15 grams per tube (NDC 0168-0242-15) and 30 grams per tube (NDC 0168-0242-30), Rx only, E. FOUGERA & CO., A division of Nycomed US Inc., Melville, New York… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent (Single Ingredient) Drug: Out-of-specification (OOS) assay results both above and below the approved specification (90-110%) were found in the recalled lots. |
| Initiation date | Mar 30, 2010 |
| Termination date | May 24, 2012 |
| City | Melville |
| State | NY |
| Country | United States |
| FEI number | 2432435 |
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