What necessitates a FDA recall is usually factored by a company’s own initiative in taking a potentially harmful and hazardous drug from the market, by FDA request, or by a FDA order that’s governed by federal statutory authority. Recalls, according to the FDA, are enforced in a tier system and there are 5 distinct forms of recall.
- “Class I Recall” is a situation where there’s a likelihood that the use of a product or exposure to it can cause adverse side effects or death.
- “Class II Recall” is a situation in which use or exposure to a certain product can cause temporary or treatment receptive consequences or where the probability of real serious health consequences are remote.
- “Class III Recall” is a situation where use of and exposure to a violative product isn’t likely to cause any real adverse side effects.
- “Market Withdrawal” occurs when a product has met a minor violation but doesn’t warrant a total sanction by the FDA. The product in question is removed by the firm its manufactured by or the firm corrects the violation. For example, tampering without evidence of manufacturing or any sort of distribution problems would result in a Market Withdrawal.
- “Medical Device Safety Alert” is issued in situations where a medical device can pose risk of substantial harm. In certain instances, these are also considered recalls.
In July of 2011, the FDA enforced a pilot program to notify people about recalls before they had been classified. The “Enforcement Report” is filed every Wednesday with the headlines, “Recalls Pending Classification: DRUGS” and products that are in question will be posted once a determination has been made regarding what level of a recall they are to be placed under.