Cetrotide — Class II drug recall D-1379-2020
Terminated recall by EMD Serono, Inc., reported 2020-07-15, distributed nationwide. Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers coul
| Recall number | D-1379-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EMD Serono, Inc., Rockland, MA, United States |
| Recall initiated | 2020-06-29 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 30,756 vials |
| Reason classes | sterility, packaging |
| NDC | 44087-1225, 44087-1225-01 |
| Lot numbers | 8J025A, 8J025B |
| Expiration dates | 2020-09-30 |
Product
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
Reason for recall
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1379-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.