1. Issue Reported – Regulatory/Internal/Customer

• a. Gather Details From Reporting Party
• i. Product, Pack Date, Grower, Ranch, Lot, Etc.
• b. Determine Severity of Complaint

2. Church Brothers/True Leaf Assembles Recall Team

3. Establish Class of Recall

• a. Class I : Reasonable Probability that use of product will cause serious adverse health consequences or death
• b. Class II: Remote Probability that use of product will cause adverse health consequences
• c. Class III: Use of product will not cause adverse health consequences

4. Church Brothers / True Leaf contacts FDA to Report Recall

5. CB/ True Leaf Traces Product Information

• a. Identity of Product
• b. Reason for product removal/ withdrawal
• c. Evaluation of risk associated with product
• d. Total amount of involved product and length of production
• e. Total amount of involved product estimated to be in distribution channels
• f. Distribution Information – Number and Identity
• g. Proposed Strategy for Conducting Recall

6. Inform Involved Customers of Recall Situation

• a. Inform Customers of product, size, lot #, manufacturers code, label, order #, and/or any other information needed to identify product
• b. Specifically instruct customers what to do with recalled product
• c. Instruct all customers to notify all those who have been distributed recalled product

7. Recall Effectiveness Check – Verify that all customers have received notification about the recall and are taking appropriate action.

8. Recall Termination – Recall is ended when the FDA determines all efforts have been made to remove or correct the recalled product.