Drug recall
Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, 3…
FDA recall event 26568 · Class II · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 26568 |
|---|---|
| Recall numbers | D-304-3 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, 3 Patient Calendar Packs of 8 Systems, Rx only, Manufactured by: Noven Pharmaceuticals, Inc… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotency (estradiol/NETA) and Degradation failure (excess primary estradiol degradant) |
| Initiation date | Jul 3, 2003 |
| City | Suffern |
| Country | United States |
| FEI number | 2416082 |
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