Drug & medication recalls Moderate risk

EMD Serono, Inc. recalls Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: E…

Recall date
June 29, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1379-2020
FDA classification
Class II
Brand / firm
EMD Serono, Inc.
Sold / distributed
Nationwide in the US

Why it was recalled

Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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