Drug Recalls Flashcards

Questions and Answers

What does a Class 1 recall cause?

Temporary health problems

Minor issues

No adverse health problems

Serious health consequences or death (correct)

Give an example of a Class 1 recall.

Label mix-up of two potent drugs, wrong strength, defective heart valve.

At what levels would a Class 1 recall occur?

Wholesale, retail, and consumer levels.

What does a Class 2 recall cause?

Temporary and reversible health problems Signup and view all the answers

Provide an example of a Class 2 recall.

Subpotent drug products, and contact issues. Signup and view all the answers

At what levels would a Class 2 recall occur?

Wholesale and retail levels. Signup and view all the answers

What characterizes a Class 3 recall?

Not likely to cause adverse health problems Signup and view all the answers

Give an example of a Class 3 recall.

Inclusion of material not intended to be in the product: dirt, plastic, animal parts. Signup and view all the answers

At what level would a Class 3 recall occur?

Retail level. Signup and view all the answers

What is the consumer level in recalls?

Affects the patient or physician Signup and view all the answers

What does the retail level affect?

Pharmacy, dispensing physicians, clinics, hospitals, and LTC (product hasn't reached patient). Signup and view all the answers

What is affected at the wholesale level?

Limited to manufacturers and retailers. Signup and view all the answers

What authority does the FDA have regarding recalls?

Both B and C Signup and view all the answers

Study Notes

Drug Recalls Overview

Class 1 recalls involve products that can cause serious health consequences or death.
Example of Class 1 recall includes laboratory mistakes, such as label mix-up of potent drugs or defective medical devices like heart valves.
Class 1 recalls are executed at wholesale, retail, and consumer levels to ensure safety across all distribution points.

Class 2 Recalled Products

Class 2 recalls pertain to products that may cause temporary or reversible health problems.
Examples include subpotent drug products and issues related to contact contamination.
These recalls are typically conducted at wholesale and retail levels.

Class 3 Recalled Products

Class 3 recalls are associated with products unlikely to cause adverse health effects.
Common examples involve contamination with extraneous materials such as dirt, plastic, or animal parts.
Class 3 recalls primarily affect the retail level, focusing on the final point of sale.

Recall Levels Explained

Consumer level recalls affect patients or physicians directly, influencing personal health.
Retail level recalls impact pharmacies, clinics, hospitals, and other dispensing entities when products haven’t reached patients.
Wholesale level recalls are strictly a matter between manufacturers and retailers, without direct consumer implication.

FDA Recall Authority

The FDA lacks the authority to initiate recalls but can take action through seizures, seizing harmful products and destroying them.
The FDA can also issue injunctions to prevent further manufacturing or distribution of unsafe products, ensuring public safety.

Description

Test your knowledge on drug recalls with these flashcards. The quiz covers different classes of recalls, their definitions, examples, and the levels at which they occur. Perfect for anyone studying pharmacology or healthcare regulations.