Drug recall
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, Rx only, Manufactured by…
FDA recall event 31171 · Class II · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 31171 |
|---|---|
| Recall numbers | D-138-5 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, FL 33186, Distributed by: Novartis Pharmaceuticals… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products |
| Initiation date | Dec 8, 2004 |
| City | East Hanover |
| Country | United States |
| FEI number | 2210396 |
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