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Center for Devices and Radiological Health division of FDA
Food and Drugs Act agency oversees the implementation of rules and regulations governing the safety, efficiency and quality of drugs and food products sold to consumers. The agency has the mandate to authorize or terminate production depending on the requirements outlined in the legislation. The Center for Devices and Radiological Health which is an FDA division ensures that drugs are suitable for human consumption and that medical devices used in treatment and research does not produce harmful gases that endanger human life as indicated by Law (2005). The agency through CDRH has been able to withdraw a number of devices and drugs that were introduced into the market but later were realized to be detrimental to human health to ensure the safety of prescribed drugs. This paper discuss the recall of tetrazepam drug pointing out its use and it is negative impact that resulted to its withdrawal.
Pirker, Misic, Brinkmeier & Frosch (2002) claims that Tetrazepum is a drug that was originally used in countries such as Australia as a muscle relaxer to treat muscle spasm and in treating anxiety disorders such as panic attacks since it contains relaxation properties. Moreover, the drug is used in the treatment of acute alcohol withdrawal symptoms such as hallucinations. In combination with other medication, it can be used to treat convulsive disorders. Although not recommended, some people use it to ease depression. The drug can be found in both liquid and solid form (pills) and exists under several brand names which include Clinoxan, Epispasm. Relaxam, Spasmorelax, Myolastan and Musaril.
Tetrazepam had already been introduced into the European Un.............
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