Standard Operating Procedure for Handling Market Recalls of Tablet Products

Department	Tablet
SOP No.	SOP/TAB/185/2025
Supersedes	SOP/TAB/185/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for managing market recalls of tablet products to ensure the timely and compliant removal of defective or non-compliant products from the market, protecting consumer health and maintaining regulatory compliance.

2. Scope

This SOP applies to all tablet products that have been released to the market and are subject to recall due to safety, quality, or regulatory issues. It includes the steps for initiating, managing, and completing a market recall.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the recall process, ensuring that all regulatory requirements are met, and communicating with regulatory authorities.
• Regulatory Affairs: Responsible for notifying and coordinating with the appropriate regulatory authorities, ensuring compliance with recall laws and regulations.
• Supply Chain/Logistics: Responsible for coordinating the physical retrieval of recalled products from the market and facilitating their proper disposal or return.
• Customer Service: Responsible for handling customer communications related to the recall, including notifications and the provision of guidance to affected customers.
• Production Team: Responsible for identifying and addressing the root cause of the issue, ensuring that corrective actions are implemented to prevent future occurrences.

4. Accountability

The QA Manager is accountable for ensuring that the recall process is managed efficiently, effectively, and in compliance with regulatory guidelines. All departments involved must ensure prompt action during the recall process.

5. Procedure

5.1 Identification of Recall Need

1. Recall initiation may be triggered by a variety of factors, including but not limited to:
   • Reports of adverse events or product defects
   • Regulatory findings
   • Non-compliance with product specifications
   • Quality control failures or deviations
2. Once a potential recall is identified, the QA team will conduct a risk assessment to determine the severity of the issue and the potential impact on patient safety.
3. If the recall is deemed necessary, the QA team will escalate the issue to senior management, Regulatory Affairs, and relevant departments for immediate action.

5.2 Notification to Regulatory Authorities

1. Immediately notify relevant regulatory authorities (e.g., FDA, EMA, local health authorities) about the recall, providing all required information such as the affected product details, reason for the recall, and steps being taken.
2. Prepare a formal recall notification document (Annexure-1) that includes:
   • Product name and batch numbers
   • Reason for recall
   • Quantity of affected product
   • Details of any adverse events (if applicable)
   • Corrective actions taken
3. Coordinate with regulatory authorities to determine the scope and method of the recall (e.g., direct notification to customers, public notice, press release).

5.3 Notification to Customers and Distributors

1. Notify affected customers, distributors, and retailers of the recall by providing clear instructions on how to return or dispose of the recalled product.
2. Provide customer service with a standard communication template (Annexure-2) that includes:
   • Recall reason and instructions for returning the product
   • Information on how to receive a refund or replacement
   • Contact information for customer support
3. Ensure that notifications are sent promptly and tracked for documentation and follow-up purposes.

5.4 Retrieval and Disposal of Affected Products

1. Coordinate the return of affected products from customers and distributors. The logistics team will manage the physical retrieval and transportation of recalled products.
2. Ensure that returned products are properly documented and segregated for disposal, return to the manufacturer, or destruction, depending on the severity of the issue (Annexure-3).
3. Any product that poses a health risk should be destroyed according to regulatory guidelines and company policy.

5.5 Investigation and Root Cause Analysis

1. Once the recall is initiated, the QA team will begin an investigation to determine the root cause of the issue that led to the recall.
2. The investigation should cover all relevant aspects, including raw materials, production processes, equipment, packaging, and storage conditions (Annexure-4).
3. Corrective and preventive actions (CAPA) must be implemented based on the findings of the investigation to prevent future recalls of the same nature.

5.6 Reporting and Documentation

1. Document all activities related to the recall process, including notifications, customer responses, inventory updates, and disposal records (Annexure-5).
2. Maintain a log of all actions taken during the recall process, including dates, personnel involved, and outcomes. This documentation must be retained for regulatory compliance.
3. Submit a final report to regulatory authorities, including a summary of the recall process, corrective actions, and any ongoing monitoring plans.

5.7 Post-Recall Review

1. Once the recall is completed, conduct a post-recall review to assess the effectiveness of the recall process and the corrective actions taken.
2. Identify any areas for improvement in the recall procedure and update SOPs as necessary.
3. Provide feedback to the regulatory authorities and ensure that all documentation is in compliance with applicable laws and regulations.

6. Abbreviations

• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• FDA: Food and Drug Administration
• EMA: European Medicines Agency

7. Documents

1. Recall Notification Document (Annexure-1)
2. Customer Notification Template (Annexure-2)
3. Product Return and Disposal Log (Annexure-3)
4. Root Cause Investigation Report (Annexure-4)
5. Recall Documentation Log (Annexure-5)

8. References

• 21 CFR Part 7 – Enforcement Policy for Recalls (US FDA)
• ISO 13485 – Medical Devices – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Recall Notification Document

Product Name	Batch Number	Recall Reason	Action Taken	Notification Date
Tablet A	Batch-12345	Packaging defect	Recall initiated, customer notification sent	01/03/2026

Annexure-2: Customer Notification Template

Subject: Urgent Recall of Tablet A – Batch 12345

Dear Customer,

We are writing to inform you that a recall has been initiated for Tablet A – Batch 12345 due to a packaging defect. Please return any affected products to us for a full refund or replacement. For more information, please contact our customer service team.

We apologize for the inconvenience and appreciate your cooperation.

Customer Service Contact: [Insert contact details]

Annexure-3: Product Return and Disposal Log

Return ID	Product Name	Batch Number	Quantity Returned	Disposition
RET-001	Tablet A	Batch-12345	500 units	Returned for disposal

Annexure-4: Root Cause Investigation Report

Batch Number	Issue Identified	Root Cause	Corrective Action	Completion Date
Batch-12345	Packaging defect	Labeling error during production	Revised labeling procedure and retraining	10/03/2026

Annexure-5: Recall Documentation Log

Document ID	Document Name	Related Batch Number	Action Taken
DOC-001	Recall Notification	Batch-12345	Notified customers, initiated recall

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated recall process	Clarified communication procedures and documentation	QA Head