Drug recall
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton…
FDA recall event 72172 · Class III · EMD Serono, Inc.
Key facts
| Event ID | 72172 |
|---|---|
| Recall numbers | D-1813-2015 |
| Recalling firm | EMD Serono, Inc. |
| Product type | Drugs |
| Products | ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. |
| Initiation date | Sep 10, 2015 |
| Report date | Sep 23, 2015 |
| Termination date | Feb 13, 2017 |
| City | Rockland |
| State | MA |
| Country | United States |
| FEI number | 1220970 |
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: