2.5 FDA requirements for medication recalls

What is a medication recall?

An action to remove a drug from the market due to safety, quality, or labeling issues

What is a manufacturer recall?

This is the most common type of recall and is voluntarily made by the manufacturer after they find a defect

What is an FDA recall?

This is the less common type of recall and is mandated by the FDA when a product poses a serious risk

What is a Class 1 Recall?

The most serious type of recall - serious harm or death is probable

What is a Class 2 Recall?

A recall that shows moderate risk - Temporary or reversible harm is possible

What is a Class 3 Recall?

This is the least severe type of recall - Harm is unlikely but it violates FDA manufacturing or labeling guidelines

What is the first step of the recall procedure?

Identify - Use NDC and Lot Number to find the recalled product

What is the second step of the recall procedure?

Pull - Immediately remove all affected stock from the shelves

What is the third step of the recall procedure?

Quarantine - Place product in a designated, separate area

What is the fourth step of the recall procedure?

Document - Record actions, quantities, and lot numbers involved

What is the fifth step of the recall procedure?

Notify & Follow - Notify the pharmacist and follow return/disposal instructions

What is a recall?

Involves a product that violates FDA law and is subject to legal action

What is a market withdrawal?

A minor product defect not subject to FDA legal action. Not a recall

True or False: The FDA initiates most recalls

False

Which recall class always requires patient notification?

Class 1 Recall