On June 29, 2020, EMD Serono, Inc. initiated a Class II recall of Cetrotide (cetrorelix acetate for Injection), 0.25 mg. The recalled product, NDC 44087-1225-1, is a sterile formulation intended for subcutaneous use only and is available by prescription.
The recall was classified as Class II by regulatory standards. The stated reason was a defective container issue. Market complaints reported missing rubber stoppers from the drug vial.
According to the recall record, missing rubber stoppers could lead to a lack of sterility assurance for the affected vials. EMD Serono, Inc., manufactured for distribution from Rockland, MD, is listed as the recalling firm.
The recall status is listed as terminated. This recall record is identified by ID D-1379-2020.
This brief reports only the facts included in the recall record. No additional details about the scope of distribution or patient impact were provided in the available data. Readers seeking more background on cetrorelix, including its approved uses and regulatory status, can consult the compound overview for further context.