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.
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
Lot numbers, UPCs & expiration codes
Lot # 8J025A; 8J025B, Exp 09/30/2020
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1379-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2020
- FDA report date
- Jul 15, 2020
- Quantity
- 30,756 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EMD Serono, Inc.
Original FDA data
Every field from FDA enforcement report D-1379-2020, exactly as published.
Show all FDA fields
- City
- Rockland
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 85938
- Address
- 1 Technology Pl
- Code information
- Lot # 8J025A; 8J025B, Exp 09/30/2020
- Postal code
- 02370-1071
- Report date
- Jul 15, 2020
- Product type
- Drugs
- Recall number
- D-1379-2020
- Classification
- Class II
- Recalling firm
- EMD Serono, Inc.
- Product quantity
- 30,756 vials
- Termination date
- Mar 11, 2022
- Reason for recall
- Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 29, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2020