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
Reported: July 15, 2020 Initiated: June 29, 2020 #D-1379-2020
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.
Details
- Recalling Firm
- EMD Serono, Inc.
- Units Affected
- 30,756 vials
- Distribution
- Nationwide in the US
- Location
- Rockland, MA
Frequently Asked Questions
What product 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. Recalled by EMD Serono, Inc.. Units affected: 30,756 vials.
Why was this product recalled? ▼
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Moderate. Recall number: D-1379-2020.
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