D-1379-2020 Class II Terminated

Recalled by EMD Serono, Inc. — Rockland, MA

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