Recalls

Question 1

recall

Answer 1

the action taken to remove a drug from the market to prevent it from being dispensed to customers on that drug and have it returned by the pharmacy to the manufacturer

Question 2

injunction

Answer 2

a court order preventing a specific action, such as the distribution of a potentially dangerous drug

Question 3

adverse effect

Answer 3

an unintended side effect of a medication that is negative or in some way injurious to a patient’s health

Question 4

Types of recall

Answer 4

recalls are, with a few exceptions, voluntary on the part of the manufacturer. The food and drug administration (FDA) may also issue a recall. Once the FDA requests a manufacturer recall of a product, the pressure to do so is substantial.

Question 5

class I (most severe)

Answer 5

where there is a strong likelihood that the product will cause serious adverse effects or death

Question 6

class II

Answer 6

where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects

Question 7

class III

Answer 7

where a product is not likely to cause adverse effects

Question 8

recall procedure

Answer 8

when a manufacturer recalls a product they will contact their customers with the following information:

• the product name, size, lot number, code or serial number, and any other important identifying information
• the lot number is what we use in the pharmacy to verify we are pulling the recalled product off the shelf
• reason for the recall and the hazard involved
• instructions on what to do with the product, beginning with ceasing distribution