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Recall Observatory FDA recall evidence

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

June 29, 2020

Class II

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

    reason.sterility_assurance · v1.0.0

    lack of sterility