Re: FDA - Public Health Advisory - Heparin
Baxter voluntarily recalls multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.
Originally Posted by www.flutrackers.com
In early February, after learning about a spike in adverse events involving this product, FDA launched a far ranging investigation in both the United States and abroad. This included inspecting Baxter’s domestic facilities, examining Heparin product in the United States and sending a team of experts to China to conduct a comprehensive inspection of the Changzhou SPL facility that makes the active ingredient for this drug.
While the FDA has yet to determine the root cause of these adverse events, we have found a Heparin-like compound that is not Heparin present in some of the Heparin Active Pharmaceutical Ingredient (API) produced by Scientific Protein Labs, which maintains a facility in Wisconsin in addition to the Changzhou plant.
This contaminant is present in significant quantities, accounting for 5 to 20 percent of the total mass of each sample tested. It reacts like Heparin in many tests, which is why the traditional release tests did not detect it.
At this point, we don’t know how the Heparin-like compound got into the Heparin Active Pharmaceutical Ingredient, but we are continuing to aggressively investigate the situation.
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