Recalls / Class II
Class IID-1379-2020
Product
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
- Brand name
- Cetrotide
- Generic name
- Cetrorelix Acetate
- Route
- Subcutaneous
- NDC
- 44087-1225
- FDA application
- NDA021197
- Affected lot / code info
- Lot # 8J025A; 8J025B, Exp 09/30/2020
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.
Recalling firm
- Firm
- EMD Serono, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Technology Pl, Rockland, Massachusetts 02370-1071
Distribution
- Quantity
- 30,756 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2020-06-29
- FDA classified
- 2020-07-08
- Posted by FDA
- 2020-07-15
- Terminated
- 2022-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1379-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.