Drug recall
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1)…
FDA recall event 82288 · Class II · Apotex Inc.
Key facts
| Event ID | 82288 |
|---|---|
| Recall numbers | D-0992-2019 |
| Recalling firm | Apotex Inc. |
| Product type | Drugs |
| Products | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. |
| Initiation date | Mar 1, 2019 |
| Report date | Mar 13, 2019 |
| City | North York |
| Country | Canada |
| FEI number | 3002906944 |
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 · Source date: