Unit 23: Drug Recalls and Hospital Coding

A pharmacy receives notice that a medication batch may cause fatal bleeding if used. What type of recall is MOST appropriate?
A. Class I
B. Class II
C. Class III
D. Market withdrawal

A. Class I

A drug is recalled because it may cause temporary dizziness but no long-term harm. What classification is this?
A. Class I
B. Class II
C. Class III
D. Not classified

B. Class II

A medication is recalled due to incorrect labeling, but poses no real health risk. What class is this?
A. Class I
B. Class II
C. Class III
D. Class IV

C. Class III

A manufacturer voluntarily removes a defective medication from the market. What is this called?
A. FDA seizure
B. Drug recall
C. Adverse event reporting
D. REMS action

B. Drug recall

Which organization oversees and classifies drug recalls?
A. DEA
B. CDC
C. FDA
D. USP

C. FDA

A technician says recalls are always initiated by the FDA. What is the BEST correction?
A. FDA always forces recalls
B. Recalls are usually voluntary by companies
C. Recalls are handled by DEA
D. Recalls only occur in hospitals

B. Recalls are usually voluntary by companies

A company violates USP standards, leading to contaminated medication. What is the MOST likely outcome?
A. DEA audit
B. Drug recall
C. Insurance denial
D. Prior authorization

B. Drug recall

What is the FDA’s role during a recall?
A. Dispense medication
B. Classify and monitor recall process
C. Prescribe alternatives
D. Manufacture drugs

B. Classify and monitor recall process

A recall is being evaluated but not yet assigned a class. How will it appear in reports?
A. Class pending
B. Not yet classified
C. Temporary recall
D. Level 0

B. Not yet classified

Where are all recalls officially listed each week?
A. DEA log
B. FDA enforcement report
C. USP bulletin
D. CDC update

B. FDA enforcement report

A recall is minor and limited in distribution. Why might it NOT be publicly announced?
A. FDA forgot
B. Low risk and limited exposure
C. Illegal to report
D. Only hospitals are notified

B. Low risk and limited exposure

A patient asks how they might learn about a recall affecting their medication. What is BEST response?
A. Only through news
B. Only through FDA website
C. Through pharmacist, doctor, or manufacturer
D. They cannot be notified

C. Through pharmacist, doctor, or manufacturer

Which recall involves risk of death or serious injury?
A. Class I
B. Class II
C. Class III
D. All equal

A. Class I

Which recall involves temporary or reversible harm?
A. Class I
B. Class II
C. Class III
D. None

B. Class II

Which recall involves no expected harm but regulatory violation?
A. Class I
B. Class II
C. Class III
D. Class IV

C. Class III

A drug has incorrect packaging but correct medication inside. What is MOST likely?
A. Class I
B. Class II
C. Class III
D. No recall

C. Class III

A drug causes mild nausea in some patients but no serious complications. What class?
A. Class I
B. Class II
C. Class III
D. None

B. Class II

A patient suddenly stops breathing in a hospital. What code is called?
A. Code Red
B. Code Black
C. Code Blue
D. Code Yellow

C. Code Blue

A fire is detected in the hospital. What code is activated?
A. Code Blue
B. Code Red
C. Code Black
D. Code Green

B. Code Red

A bomb threat is reported in a hospital. What code is used?
A. Code Blue
B. Code Red
C. Code Black
D. Code Orange

C. Code Black

Which situation would MOST likely trigger Code Blue?
A. Fire in cafeteria
B. Patient cardiac arrest
C. Suspicious package
D. Power outage

B. Patient cardiac arrest

Who is MOST likely part of a Code Blue team?
A. Cashier
B. Pharmacist
C. Receptionist
D. Insurance agent

B. Pharmacist

Which is NOT part of a Code Blue response team?
A. Doctor
B. Nurse
C. Respiratory therapist
D. Billing specialist

D. Billing specialist

A patient shows signs of stroke and confusion. What code may be activated?
A. Code Red
B. Code Black
C. Code Blue
D. No code

C. Code Blue

Smoke is smelled in a hospital hallway. What should be activated?
A. Code Blue
B. Code Red
C. Code Black
D. Code White

B. Code Red

Staff discover a suspicious explosive device. What code?
A. Code Blue
B. Code Red
C. Code Black
D. Code Yellow

C. Code Black

A visitor reports hearing about a bomb threat call. What is MOST appropriate code?
A. Code Blue
B. Code Red
C. Code Black
D. Code Green

C. Code Black

Why are hospital codes used instead of plain language?
A. Save time only
B. Prevent panic and organize response
C. Hide information
D. Reduce staff workload

B. Prevent panic and organize response

A technician moves from retail to hospital pharmacy. What new concept must they understand?
A. Insurance billing
B. Hospital emergency codes
C. DEA forms only
D. Compounding laws

B. Hospital emergency codes

Which statement is TRUE about hospital codes?
A. Standardized nationwide
B. Only used in ER
C. Not standardized across U.S.
D. Only used for fires

C. Not standardized across U.S.

A drug recall is initiated because the product could potentially cause life-threatening complications, even though no cases have been reported yet. What class?
A. Class I
B. Class II
C. Class III
D. Not classified

A. Class I

A drug causes mild rash in some patients but resolves quickly without treatment. What class?
A. Class I
B. Class II
C. Class III
D. Market withdrawal

B. Class II

A medication is recalled because the expiration date is printed incorrectly, but drug potency is unaffected. What class?
A. Class I
B. Class II
C. Class III
D. No recall needed

C. Class III

A student says: “All recalls are forced by the FDA.” What is correct?
A. True
B. False — most are voluntary by manufacturers
C. True for Class I only
D. True for hospitals only

B. False — most are voluntary by manufacturers

A pharmacy fails to follow USP standards, leading to contamination. What is MOST likely result?
A. Insurance audit
B. Drug recall
C. DEA inspection only
D. REMS activation

B. Drug recall

A recall involves a drug that may cause serious harm, but only if taken in extremely high doses. What class?
A. Class I
B. Class II
C. Class III
D. Not classified

A. Class I

Where would a technician look to find ALL current recalls?
A. Daily news
B. FDA enforcement report
C. DEA website
D. USP bulletin

B. FDA enforcement report

A recall is NOT publicly announced. What is the MOST likely reason?
A. FDA error
B. Low risk and limited distribution
C. Illegal to publish
D. Manufacturer refusal

B. Low risk and limited distribution

A recall appears in a report but has no classification yet. What does this mean?
A. It is Class III
B. It is minor
C. Still under investigation
D. It is expired

C. Still under investigation

Who decides the classification of a recall?
A. Pharmacist
B. Manufacturer
C. FDA
D. DEA

C. FDA

A patient collapses and has no pulse. What code is called?
A. Code Red
B. Code Black
C. Code Blue
D. Code Yellow

C. Code Blue

A fire alarm is triggered due to visible smoke. What code?
A. Code Blue
B. Code Red
C. Code Black
D. Code Orange

B. Code Red

A suspicious package is found in the hospital lobby. What code?
A. Code Blue
B. Code Red
C. Code Black
D. Code White

C. Code Black

Which person would NOT respond to Code Blue?
A. Nurse
B. Doctor
C. Respiratory therapist
D. Billing clerk

D. Billing clerk

A technician assumes all hospitals use the same emergency codes nationwide. What is correct?
A. True
B. False — codes are not standardized
C. True for federal hospitals only
D. True for ER only

B. False — codes are not standardized

How is Code Blue typically activated?
A. Email notification
B. Emergency button or phone call
C. Written report
D. Insurance alert

B. Emergency button or phone call

A patient shows sudden confusion, slurred speech, and weakness. What is MOST appropriate?
A. Code Red
B. Code Black
C. Code Blue
D. No action

C. Code Blue

Why are codes used instead of plain language?
A. Save time only
B. Prevent panic and organize response
C. Hide emergencies
D. Legal requirement only

B. Prevent panic and organize response

A drug recall is issued for a product that “may cause serious injury or death.” What else is TRUE?
A. It is always unannounced
B. It is Class I
C. It is minor
D. It is optional to follow

B. It is Class I

Which situation involves BOTH recall knowledge AND patient safety responsibility?
A. Ignoring recall notice
B. Informing patients about recalled medication
C. Filing insurance claims
D. Counting inventory

B. Informing patients about recalled medication

A drug is recalled for labeling error AND causes mild headache. What class?
A. Class I
B. Class II
C. Class III
D. No recall

B. Class II

A pharmacist receives a Class I recall notice. What is the MOST urgent action?
A. File paperwork later
B. Remove product immediately
C. Wait for patient complaints
D. Notify DEA

B. Remove product immediately

A patient asks if their medication is affected by a recall. What should the technician do FIRST?
A. Guess based on memory
B. Check official recall information
C. Ignore question
D. Refer to insurance

B. Check official recall information

Class III recall means:
A. Dangerous
B. Temporary harm
C. No expected harm but violation
D. Death risk

C. No expected harm but violation

Code Black ALWAYS refers to:
A. Death
B. Fire
C. Bomb threat
D. Cardiac arrest

C. Bomb threat

Which is MOST life-threatening?
A. Class III recall
B. Class II recall
C. Class I recall
D. All equal

C. Class I recall