Requirements for a Drug Recall

On occasion, a drug is recalled and taken off the market. Recalls can occur with prescription medications, over-the-counter drugs or dietary supplements. The organization in the United States that oversees the recall of drugs is the Food and Drug Administration. Drugs may be withdrawn voluntarily from the manufacturer, as a request made by the FDA or by an order through the FDA.

Manufacturer Recall

• Both prescription and over-the-counter medications are subject to drug recall.

  In some instances, a drug maker may decide to make a voluntary recall of its product. This is known as a "market withdrawal." In these instances, the manufacturer becomes aware of what the FDA calls a "minor violation," which is not covered under the guidelines set by the FDA for recall. These violations include such things as package tampering, which does not reflect on the quality or effectiveness of the original medication. Probably the most famous case of drug recall caused by tampering is the voluntary withdrawal of Tylenol in 1982 when it was discovered that some bottles had been opened and spiked with cyanide. The FDA states that manufacturer recall is conducted because either the manufacturer or distributor recognizes there is a public health concern with the product.

The Role of the FDA

• Watch groups other than the FDA keep track of drug recalls.

  According to its website, the Food and Drug Administration has three class levels of recall. Class I is when the FDA recognizes there is a "reasonable probability" that a drug will cause serious health complications or even death if the drug is taken. Class II withdrawals occur when the use or exposure to a drug may cause adverse reactions or the "probability of serious health consequences is remote." A Class III recall happens when the drug is not likely to present any serious public health concerns.

Why a Recall?

• According to the FDA, drugs are recalled because they present a risk of injury, are defective in their intent and purpose, or pose a deception to the public. The FDA conducts a survey to ascertain the claims made by the drug manufacturer, determines if the drug poses any injurious effects from its use, and weighs the benefits and risk. If there is scientific evidence to support that a drug can be deemed a health hazard, it is subject to recall. Assessments are made as to how the drug affects patients, the seriousness of the health hazards and the likelihood of the hazards occurring in the patient population.

  After the determination, the recall is classified I, II or III, and the FDA commissioner or a designee informs the manufacturer of the potential hazards and either recommends or commands a recall.