At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California.

Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe. These kits are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use. The kits also are branded incorrectly because their labeling does not contain adequate directions for their use and they were manufactured under conditions not in compliance with current Good Manufacturing Practice.

In October 2008, the FDA issued a warning letter to Keystone’s contract manufacturer, PrimaPharm of San Diego. 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. The FDA also twice warned Keystone verbally that it should not distribute the unapproved drugs in the cyanide antidote kits.