FDAClass IIJuly 15, 2020

Cetrotide recall: Sterility Concern

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

Why was Cetrotide recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 8J025A; 8J025B, Exp 09/30/2020

Product
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD…
Recalling firm
EMD Serono, Inc.
Quantity
30,756 vials
Distribution
Nationwide in the US
Recall date
July 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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