Drug recall
fougera BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone), 60 mL, NDC…
FDA recall event 34259 · Class III · Nycomed US Inc.
Key facts
| Event ID | 34259 |
|---|---|
| Recall numbers | D-101-6, D-102-6, D-103-6, D-104-6, D-105-6, D-106-6 |
| Recalling firm | Nycomed US Inc. |
| Product type | Drugs |
| Products | fougera BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone), 60 mL, NDC 0168-0057-60 --- FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only --- E. FOUGERA & CO. a…, fougera BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone), 60 mL, NDC 0168-0041-60 --- FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only --- E. FOUGERA & CO. a…, fougera CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%, 50 mL, NDC 0168-0269-50 --- FOR USE ON THE SCALP FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only --- E. FOUGERA & CO. a division of…, fougera FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%, 60 mL, NDC 0168-0059-60 --- FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only --- E. FOUGERA & CO. a division of Altana Inc…, fougera TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 60 mL, NDC 0168-0336-60 --- FOR DERMATOLOGIC USE NOT FOR OPHTHALMIC USE, Rx only --- E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK… and 1 more |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Dropper: The dropper plug does not meet specification in that the container/closure component cannot ensure an adequate opening for dispensing the drug product. |
| Initiation date | Dec 15, 2005 |
| Termination date | Apr 22, 2008 |
| 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