Drug 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
D-1379-2020
Product summary
- Firm
- EMD Serono, Inc.
- Event
- Event 85938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,756 vials
- Official record key
drug-enforcement:D-1379-2020
Official wording
Reason: Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Code information: Lot # 8J025A; 8J025B, Exp 09/30/2020
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility