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WorksheetsFDA Recall
Total questions: 20
Worksheet time: 10mins
A manufacturer discovers a problem with a particular oral syringe. Although the plunger sometimes becomes tight and difficult to push, the patient still receives all of the medication. Which of the following recalls does the FDA request?
Class I
Class II
Class III
Class IV
Which of the following drug recall classes is the most severe?
Class II
Class III
Class I
Class IV
Which of the following may issue pharmaceutical recalls?
Manufacturers
Drug Enforcement Administration
Wholesalers
Department of Health and Human Services
Who is responsible for issuing voluntary or mandated drug recalls to customers?
Drug Enforcement Administration (DEA)
Manufacturers
Wholesalers
Department of Health and Human Services
The Drug Enforcement Administration (DEA) is responsible for issuing drug recalls.
True
False
Which department is responsible for providing public access to essential health services but does not issue drug recalls?
Drug Enforcement Administration (DEA)
Manufacturers
Wholesalers
Department of Health and Human Services
Fill in the blank: The FDA provides a searchable list of recalled drugs on its website, which is essential for ______ to remove and manage recalled products.
pharmacies
patients
manufacturers
doctors
Which of the following is included in the FDA's recall list information?
Brand name
Recall classification
Date of recall
Product description
All the above
A drug recall is a voluntary action taken by a company to remove a defective or potentially harmful product from the market.
True
False
Fill in the blank: The FDA works with ______ to develop recall strategies, monitor the effectiveness of the recall process, and determine if further action is needed.
manufacturers
consumers
retailers
distributors
Which of the following recall classes includes a drug recall in which the use of or exposure to the violative substance is not likely to cause adverse health consequences?
Which of the following should a pharmacy do upon receiving notification of a drug recall?
Contact the insurance company
Remove the recalled product from the inventory
Destroy the recalled product immediately
Discuss the recall and its severity at the end of the day
All of the following are reasons for a drug manufacturer to recall a product EXCEPT:
Production errors
Incorrect bottle size
Product contamination
Incorrect labeling
You are the inventory pharmacy technician and a manufacturer recall notice appears for one lot number of an insulin pen already on your shelf. What should you do about the recalled lot?
Continue using the lot until stock is depleted since it is the same NDC.
Only remove units that have visible damage or discoloration.
Mark the units "use last" but keep them on shelf.
Quarantine all remaining units of that lot, notify the pharmacist, and follow recall protocol.
A drug recall is based on which of the following information?
Package size
Manufacture date
product code
Lot number
You are the inventory pharmacy technician at a hospital outpatient pharmacy. During a routine stock audit, you notice two cases of the same NDC for an insulin pen stored on the shelf. One case has an earlier expiration date, and the other has a later expiration date. During this same shift, a manufacturer recall notice appears in the pharmacy system for one specific lot number of this insulin pen. What should you do about the recall notice for lot AB123?
Continue using the lot until stock is depleted since it is the same NDC.
Only remove units that have visible damage or discoloration.
Mark the units "use last" but keep them on shelf.
Quarantine all remaining units of that lot, notify the pharmacist, and follow recall protocol.
Which organization's website provides a searchable list of recalled drugs?
ISMP
EPA
FDA
TJC
Which of the following is least likely to be a reason for a Class III recall?
A. Minor labeling error
B. Incorrect expiration date
C. Contamination with harmful bacteria
D. Packaging defect that does not affect safety
A pharmacy receives a notice that a batch of 50 mg tablets was mislabeled as 25 mg. The pharmacy has already dispensed some. What recall class does this fall under?
A medication may be recalled for which of the following common reasons?
An equivalent brand becomes available
A counterfeit drug has been detected
The drug manufacturer goes out of business
A generic equivalent becomes available
