Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall action is to be undertaken. This is based on the significance of the risk and the channels through which the goods have been distributed. The recall action levels are / Wholesale / Hospital / Retail / Consumer. Wholesale - includes wholesalers and state purchasing authorities. Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue banks and laboratories as well as wholesale as appropriate. Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale and hospital as appropriate. Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate. v Recall Action Classification**: Recall actions of therapeutic goods are classified based on the potential risk the deficiency poses to patients / consumers. They are classified as Class I, Class II or Class III. Class I - A situation in which there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious adverse health consequences or death. Class II - A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Class III- A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences.