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

FDA recall notice · announced July 15, 2020 · Emd Serono

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot # 8J025A; 8J025B, Exp 09/30/2020
Quantity: 30,756 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.