The downside of creating this form of hemoglobin, called methemoglobin, is that it cannot carry oxygen. This will pull the cyanide out of the mitochondria of the cells and allow the resumption of normal energy production. One of the treatments for cyanide poisoning is to turn some of the hemoglobin in the body into a form that will attach to cyanide.

Next, there is Sodium Nitrate for IV administration. First, there is Amyl Nitrite for inhalation. These are in short supply - often there is only one or two available to each emergency department.

It is also known as the Lilly Kit, Pasadena Kit or the Taylor Kit. Keystone was given numerous opportunities to come into compliance, but the company failed to cease distributing the unapproved new drugs.In the hospital, a common treatment is the Cyanide Antidote Kit. The FDA also twice warned Keystone verbally that it should not distribute the unapproved drugs in the cyanide antidote kits.Īfter an FDA inspection of PrimaPharm between August and September 2009 found continuing cGMP violations, the contract manufacturer said it would no longer accept orders from Keystone to manufacture the injections or kits.Īn FDA inspection of Keystone between September and October 2009 revealed that the firm had continued to distribute the unapproved drugs in the cyanide antidote kits still in inventory and did not intend to stop. That letter identified numerous cGMP violations and informed PrimaPharm that the Keystone Sodium Thiosulfate Injection and the Keystone Sodium Nitrite Injection were unapproved new drugs. In October 2008, the FDA issued a warning letter to Keystone’s contract manufacturer, PrimaPharm of San Diego. “This action is a significant step in protecting the public health.” “The FDA is taking this action because Keystone has refused to take these unapproved products off the market,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.

Cyanide antidote kit contains