Abstract

DRUG RECALL: AN OVERVIEW

*Siraj Sundaran¹, Sundaram Sankar², P. Dhamodaran², and S. Mohammed Saji²

¹Devaki Amma Memorial College of Pharmacy, Malappuram, India
²Department of Pharmacy Practice, JSS College of Pharmacy, Ooty, Tamil Nadu, JSS University, India.

Abstract

Drug prescribing is the most vital element of the medical field. The safety of drug products approved by the US Food and Drug Administration is conducted in a small number of people before it comes to the market. All the adverse effects and toxicities cannot be elicited in the limited number of volunteers used in the phased trial so some problems can remain unknown and can only be discovered when a product is used in large number of people or after prolonged use. A drug recall process is an approach of the drug regulatory bodies to withdraw the drugs that can cause potential harm or deficit in its safety or efficacy. The process can be time consuming leaving the dangerous prescription drugs on the current market and also in the hands of consumers. Other than the regulatory bodies the responsibilities to monitor a drug and to avoid its use after its recall also lays in the hand of the pharmaceutical companies, the healthcare professionals and last but not the least the consumers. This review is an attempt to create awareness about drugs that are no longer used due to lack of safety and can aid in being cautious regarding the drugs of same genus in the future.

Keywords: drug recall, recall classification, withdrawal reasons, Indian scenario.