Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Merck KGaA. FDA records under 4 spellings of its name, each linked to the record. See the Merck KGaA group view.
As of Nov 13, 2026, FDA's public records list EMD Serono, Inc. with 19 drug applications, 2 drug recalls and 1 complete response letter. The most recent is a drug recall dated Jun 29, 2020: Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use onl….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 29, 2020 | Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., RockClass II · Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to | Drug recalls |
| Sep 10, 2015 | ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In IsraelClass III · Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. | Drug recalls |
| Feb 28, 2011 | Complete response letter, NDA 022561Approved | Complete response letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
