Appendix 6: Recall Notice Templates in New Zealand

1. Purpose of the Templates

Appendix 6 contains standardized recall notice templates to assist sponsors in preparing consistent, clear, and effective communications during recall actions for therapeutic products in New Zealand. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf These templates ensure that all critical information is included and presented in a structured format, helping recipients understand the issue and take appropriate action promptly. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

2. Types of Recall Notice Templates

The appendix provides separate templates tailored to different recall levels:

• Consumer Level Recall Notice — Directed to patients/end-users, written in plain language with emphasis on immediate actions (e.g., stop using, return product). https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf
• Retail/Healthcare Professional Level Notice — Targeted to pharmacies, hospitals, clinics, and prescribers, including more technical details and instructions for quarantine, return, or patient notification. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf
• Trade/Wholesale Level Notice — For distributors and wholesalers, focusing on stock quarantine, return arrangements, and onward communication if required. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

Each template is designed to match the urgency and audience of the recall class and level. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

3. Key Elements in the Templates

All templates include standard sections with placeholders for sponsors to fill in:

• Recall reference number and date
• Product name(s), strength(s), pack size(s), batch/lot number(s), expiry date(s)
• Sponsor/company name and contact details
• Reason for recall (brief description of the defect or risk)
• Potential health risk or consequence
• Recommended actions (e.g., cease distribution/use, quarantine, return)
• Instructions for returning stock or reporting adverse events
• Statement that the recall is being conducted with Medsafe’s knowledge
• Contact point for questions (phone/email) https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

4. Usage Guidelines

• Sponsors should customize the templates with accurate product and recall details.
• Use the appropriate level template based on the recall strategy approved by Medsafe.
• For medical devices, templates may be adapted for field safety notices (FSNs) where corrective actions (e.g., software update) are involved instead of full product return. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf
• Notices should be distributed promptly via agreed channels (direct mail, email, website publication).

5. Importance of Standardized Notices

Using these templates promotes:

• Consistency across recalls
• Completeness of essential information
• Clarity for recipients
• Compliance with Medsafe expectations
• Effective risk communication to minimize patient harm https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

6. Additional Notes

The templates are provided in editable format (e.g., Word) within the Recall Code document. Sponsors are encouraged to consult Medsafe if clarification is needed on wording or content. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf

These standardized templates support efficient and transparent recall processes for medicines and medical devices in New Zealand. https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf