D-1379-2020 Class II Terminated
FDA drug recall D-1379-2020 was initiated by EMD Serono, Inc. on June 29, 2020 and is designated Class II. Reason for recall: Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance. The recall status is terminated (terminated March 11, 2022). Affected quantity: 30,756 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 15, 2020
- Initiation Date
- June 29, 2020
- Termination Date
- March 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,756 vials
Product Description
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.
Distribution Pattern
Nationwide in the US
Code Information
Lot # 8J025A; 8J025B, Exp 09/30/2020