Drug recall
Estraderm¿ (estradiol transdermal system) 0.05 mg/day, Rx only. 8 individual sealed patches/systems per…
FDA recall event 32370 · Class III · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 32370 |
|---|---|
| Recall numbers | D-282-5, D-283-5 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Estraderm¿ (estradiol transdermal system) 0.05 mg/day, Rx only. 8 individual sealed patches/systems per patient calendar pack, 6 patient calendar packs per pharmacy shelf box. Each patient calendar…, Estraderm¿ (estradiol transdermal system) 0.1 mg/day, Rx only. 8 individual sealed patches/systems per patient calendar pack, 6 patient calendar packs per pharmacy shelf box. Each patient calendar… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: the patient booklet contained in each patient calendar pack of 8 systems does not include the required current black box warning for estrogens as contained in the approved NDA labeling (the… |
| Initiation date | Jun 14, 2005 |
| 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