Drug recall
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister…
FDA recall event 83408 · Class I · Jubilant Cadista Pharmaceuticals, Inc.
Key facts
| Event ID | 83408 |
|---|---|
| Recall numbers | D-1837-2019 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed dissolution specifications : failed results at the 3-month stability time point. |
| Initiation date | Jul 9, 2019 |
| Report date | Aug 7, 2019 |
| Termination date | May 7, 2021 |
| City | Salisbury |
| State | MD |
| Country | United States |
| FEI number | 1000513046 |
At a glance
- 1–9 Products in this recall
- 1–9 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: