Last Updated: May 7, 2026
1. Purpose
This policy establishes the procedures Practitioners must follow in the event of a product recall, market withdrawal, or safety alert issued by Company. Practitioner’s prompt cooperation is essential for consumer safety and regulatory compliance.
2. Notification
Company will notify Practitioner of any recall, market withdrawal, or safety alert by email, Practitioner Portal notification, or other reasonable means. The notice will include:
- Affected Product(s), including lot numbers
- Nature of the issue and reason for the recall
- Required actions and timeline
- Contact information for recall-related questions
3. Practitioner Obligations Upon Recall Notice
Upon receiving a recall notice from Company, Practitioner must immediately take the following actions:
3.1 Stop Sale
Immediately cease all sales, distribution, and dispensing of affected Products. Remove affected Products from shelves, website listings, and any other sales channels.
3.2 Quarantine Inventory
Physically separate affected Products from all other inventory. Store quarantined Products in a secure, clearly marked location. Do not discard, destroy, return, or otherwise dispose of affected Products until instructed by Company.
3.3 Inventory Accounting
Within 48 hours of the recall notice (or such other timeline as specified by Company), provide Company with a complete accounting of affected inventory, including:
- Lot numbers and quantities on hand
- Storage location(s)
- Quantities previously sold or dispensed, with dates
3.4 Patient and Customer Notification
Distribute Company-approved recall notices to affected patients and customers as directed by Company. Follow Company’s instructions regarding the timing, method, and content of notifications.
Practitioner may independently communicate factual safety information to patients and customers if required by law or reasonably necessary for immediate patient safety. Such communications must be consistent with Company’s recall notices and must not include speculative, editorial, or unapproved content.
3.5 Transaction Records
To the extent lawful, provide Company with transaction records for affected Products to facilitate the recall. De-identify patient information where practical and consistent with the purpose of the recall.
4. Return and Disposition of Recalled Products
- Company will provide instructions for return or destruction of recalled Products.
- Company will bear reasonable return shipping costs for recalled Products.
- Practitioner must not resell, donate, liquidate, transfer, or otherwise dispose of recalled Products except as instructed by Company.
- If Company instructs destruction, Practitioner must provide written certification of destruction.
5. Public Statements
- Practitioner must not issue any public statement regarding a recall except Company-approved recall notices or as required by law.
- All media inquiries regarding a recall must be directed to Company.
6. Cooperation
Practitioner must cooperate fully with Company’s recall efforts, including providing information, facilitating inspections, assisting with patient follow-up, and taking any other actions reasonably requested by Company.
Failure to cooperate with recall procedures is grounds for immediate termination of Practitioner’s participation in the Program.
7. Recall Obligations Survive Termination
Practitioner’s obligations under this Recall Policy survive termination of the Practitioner Wholesale Agreement for the shelf life of Products sold to Practitioner.