Drug recall
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral…
FDA recall event 64118 · Class III · Sandoz Incorporated
Key facts
| Event ID | 64118 |
|---|---|
| Recall numbers | D-152-2013 |
| Recalling firm | Sandoz Incorporated |
| Product type | Drugs |
| Products | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. |
| Initiation date | Jan 22, 2013 |
| Report date | Feb 13, 2013 |
| Termination date | May 7, 2013 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 1717759 |
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 · Source date: