Returns and recalls MCQs With Answer

Introduction: Returns and recalls are critical components of pharmaceutical quality management, ensuring patient safety and regulatory compliance. This set of MCQs is designed for M.Pharm students studying Quality Management Systems (MQA 102T). The questions cover definitions, regulatory frameworks, classification of recalls, reasons for product returns, quarantine and disposition procedures, effectiveness checks, traceability, communication strategies, and corrective actions. By practicing these targeted items, students will deepen their understanding of practical and regulatory aspects of recalls and returns, enhance decision-making skills during product quality events, and prepare for real-world responsibilities in pharmaceutical quality assurance and regulatory affairs.

Q1. What is the primary regulatory purpose of initiating a product recall in the pharmaceutical industry?

• To recover financial losses from defective batches
• To protect public health by removing or correcting a product that presents a risk
• To downgrade product quality classification
• To prevent competitors from using similar formulations

Correct Answer: To protect public health by removing or correcting a product that presents a risk

Q2. Which term specifically refers to unsaleable product returned by distributors or pharmacies due to quality or regulatory concerns?

• Market withdrawal
• Product return
• Field correction
• Recall order

Correct Answer: Product return

Q3. Which of the following best distinguishes a voluntary recall from a mandatory recall?

• Voluntary recalls are only for expired products; mandatory recalls are for contamination
• Voluntary recalls are initiated by the manufacturer; mandatory recalls are ordered by regulatory authorities
• Voluntary recalls require public notification; mandatory recalls do not
• Voluntary recalls do not require record keeping; mandatory recalls do

Correct Answer: Voluntary recalls are initiated by the manufacturer; mandatory recalls are ordered by regulatory authorities

Q4. The FDA recall classification that indicates a reasonable probability that use of the product will cause serious adverse health consequences or death is:

• Class III
• Class II
• Class I
• Market withdrawal

Correct Answer: Class I

Q5. When a batch is suspected of contamination, what immediate action should the manufacturer take first?

• Destroy all remaining inventory without testing
• Initiate quarantine of the affected lots and stop distribution
• Inform the media about the potential contamination
• Issue final disposition to the market

Correct Answer: Initiate quarantine of the affected lots and stop distribution

Q6. Which document outlines the step-by-step process a pharmaceutical company follows to manage a recall?

• Standard Operating Procedure (SOP) for Recalls and Market Withdrawals
• Batch Manufacturing Record (BMR)
• Material Safety Data Sheet (MSDS)
• Clinical Study Report

Correct Answer: Standard Operating Procedure (SOP) for Recalls and Market Withdrawals

Q7. What is the purpose of a recall effectiveness check?

• To calculate recall-related financial losses
• To verify that recalled product was successfully located and removed from distribution
• To confirm the identity of the recall initiator
• To obtain new marketing authorization

Correct Answer: To verify that recalled product was successfully located and removed from distribution

Q8. Which of the following is NOT typically considered a valid reason for initiating a recall?

• Labeling omissions that could lead to misuse
• Confirmed microbial contamination in a finished batch
• Minor aesthetic packaging flaw with no safety impact
• Presence of a known undeclared allergen

Correct Answer: Minor aesthetic packaging flaw with no safety impact

Q9. Traceability in the returns and recalls process primarily enables which activity?

• Identification of all downstream recipients of a specific lot
• Calculation of production costs per batch
• Enhancing marketing reach to new customers
• Reducing shelf life of a product intentionally

Correct Answer: Identification of all downstream recipients of a specific lot

Q10. After a recall, what regulatory report is commonly required by authorities to summarize the recall actions and outcomes?

• Recall effectiveness questionnaire
• Final recall report or recall termination report
• Batch release certificate
• Annual product review

Correct Answer: Final recall report or recall termination report

Q11. Which root cause investigation tool is widely used to analyze causes of a recall or product return?

• Fishbone (Ishikawa) diagram
• Placebo-controlled trial
• Market segmentation analysis
• Cost-benefit analysis

Correct Answer: Fishbone (Ishikawa) diagram

Q12. In a recall scenario, what is the best practice for communicating with healthcare professionals and patients?

• Delay communication until completion of all investigations
• Provide clear, timely, and factual information including actions to take
• Use only internal memos without public announcements
• Avoid providing any guidance to prevent legal exposure

Correct Answer: Provide clear, timely, and factual information including actions to take

Q13. Which action differentiates rework from reprocessing in pharmaceutical returns handling?

• Rework changes the product’s primary identity; reprocessing improves labeling only
• Rework restores product to its originally intended quality without changing formulation; reprocessing repeats a validated manufacturing step
• Rework always requires regulatory approval; reprocessing never does
• Rework is done on-site; reprocessing is outsourced only

Correct Answer: Rework restores product to its originally intended quality without changing formulation; reprocessing repeats a validated manufacturing step

Q14. Which record is essential to retain when handling a returned lot pending investigation?

• Customer purchase history unrelated to the return
• Quarantine log and return disposition documentation
• Employee annual leave records
• Marketing campaign schedules

Correct Answer: Quarantine log and return disposition documentation

Q15. A recall triggered by a labeling error that could lead to serious dosing mistakes would most likely be classified as:

• Class III recall
• Class I recall
• Market withdrawal
• Product return only

Correct Answer: Class I recall

Q16. Which factor is LEAST relevant when determining the scope of a pharmaceutical recall?

• Distribution pattern and number of units shipped
• Probability and severity of harm to patients
• Cost to the manufacturer for retrieving product
• Possible routes of administration and vulnerable populations affected

Correct Answer: Cost to the manufacturer for retrieving product

Q17. What is a Field Correction in the context of pharmaceutical safety actions?

• A permanent market withdrawal of a product line
• An action to correct a product in the field without physically removing it from the market
• Destruction of product at manufacture site only
• A type of mandatory recall ordered by courts

Correct Answer: An action to correct a product in the field without physically removing it from the market

Q18. During a recall, what is the importance of retaining retained samples from the suspected lot?

• They are used exclusively for marketing purposes
• They enable confirmatory testing, root cause analysis, and regulatory review
• They should be sold to recover costs
• They are only held for legal depositions and otherwise irrelevant

Correct Answer: They enable confirmatory testing, root cause analysis, and regulatory review

Q19. Which regulatory expectation applies to recalls in terms of timelines?

• There are no timeline expectations; companies can act at their discretion
• Regulators expect prompt initiation, timely notifications, and periodic status updates until closure
• Manufacturers must wait 90 days before any public communication
• Recall actions must be completed within 24 hours regardless of complexity

Correct Answer: Regulators expect prompt initiation, timely notifications, and periodic status updates until closure

Q20. Which corrective action is most appropriate after completing a recall investigation that identified a process deviation as root cause?

• Implement a CAPA (Corrective and Preventive Action) plan and update procedures
• Ignore the deviation if no adverse events were reported
• Only perform additional product inspections without procedural change
• Decrease batch testing to speed production

Correct Answer: Implement a CAPA (Corrective and Preventive Action) plan and update procedures

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