Drug Maker's Unapproved Pharmaceutical Drugs Cracked Down by US Marshal
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The US Marshal confiscated $39,000 in pharmaceutical drugs and products manufactured by Keystone Pharmaceuticals at their headquarters in Laguna, California at the FDA’s behest. Keystone had been manufacturing unapproved antidote kits containing pharmaceutical drugs designed to cure cyanide poisoning. The company distributes its products to hospitals and doctors offices throughout the US and Canada. Keystone’s product has not yet been proven safe or effective and has not met FDA approval.
Cyanide is a lethal poison that renders the body’s cells incapable of using oxygen. Cyanide poisoning can originate from a variety of sources, specifically smoke inhalation where plastics, rubber and silk are being burnt, as well as the ingestion, exposure or inhalation of cyanide contaminated chemicals in photography, chemical research, metal and plastic processing environments.
Unsafe Ingredients
The prescription drugs in Keystone’s cyanide antidote contain both a Sodium Thiosulfate and a Sodium Nitrite injection stored in vials, along with accompanying needles and syringes. Neither ingredient has been FDA approved for use. Two warnings in 2009 instructing the company to cease manufacturing the products preceded the US Marshall seizure and were ignored. FDA inspections in October and November 2009 revealed that the company continued to produce and distribute the pharmaceutical drugs without authorized approval.
Responsible for protecting public health, the US District Court for the Central District of California issued a seizure warrant against the company. Although no reports have been released documenting any adverse reactions or fatalities resulting from the unapproved drugs, the FDA has nonetheless issued a July 22, 2010 press release regarding the unapproved cyanide pharmaceutical drugs.
