FDA recall D-1379-2020

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.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-06-29

Report date

2020-07-15

Termination date

2022-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockland, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1379-2020