EMD Serono, Inc. initiated a recall of Cetrotide (cetrorelix acetate for Injection) 0.25 mg on June 29, 2020. The recall is classified as Class II by the FDA. The action, identified as D-1379-2020, involved the product manufactured for EMD Serono, Rockland, MD, under NDC 44087-1225-1.
The stated reason for the recall is a defective container. 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 product.
The recall status is listed as terminated. Cetrotide is indicated for subcutaneous use only and is available by prescription. This report reflects only the facts contained in the FDA recall record referenced here and does not characterize the clinical significance of the issue beyond what is stated.
Readers interested in general background on cetrorelix, including its approved indications and regulatory status, can consult the compound overview for additional context.