Heparin Test Results

Please send all test results to the U.S. FDA at: cderrecalls@cder.fda.gov or call 301-796-3358.

Please provide the following information regarding heparin testing:

1. Name
2. Company
3. Telephone number
4. Email address
5. Lot # of heparin sample
6. Date heparin sample was manufactured
7. Source of Heparin: API, Finish Product, Crude/Bulk, or Other
8. Proton NMR Results (FDA Web Page Method): Two Peaks (Yes/No) – Date performed
9. Capillary Electrophoresis (FDA Web Page Method): Two Peaks (Yes/No) – Date performed
10. Additional Tests performed
11. Comments on results of test data
12. Conclusion: FAIL (Suspect or Atypical) or PASS (Not Suspect or Typical)
13. Heparin Sample associated with increased Adverse Events (Yes/No/Unknown)