Class II · Moderate risk
Cetrorelix Acetate for Injection
Defective Delivery System: Missing or duplicated needles within the injection kit
Cetrotide (cetrorelix acetate for Injection)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
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
Affected NDC
44087-1225-01
Compare with the code on your package — it is the most precise check available.
Drug: Cetrorelix
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cetrotide cetrorelix acetate NDC 44087-1225 |
Kit Subcutaneous |
EMD Serono, Inc. | Rx |
- Recalling firm
- EMD Serono, Inc.
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1379-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cetrorelix recalls
See all
Class II · Moderate risk
Cetrorelix Acetate for Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by EMD Serono, Inc.
All 2020 recalls
Class III · Low risk
ClomiPHENE CITRATE Tablets
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Other packaging defect recalls from 2020
All packaging defect recalls
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class III · Low risk
Desflurane
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk
Childrens Dimetapp Cold & Cough
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
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