A recall is when a dietary supplement distributor or manufacturer removes a product from the market because of either mislabeling or the product presents a health hazard due to contamination, foodborne illness outbreak, or other reasons.
Some types of mislabeling that could result in a recall include undeclared ingredients such as fish or shellfish, undeclared allergens such as eggs, wheat, etc.
Recalls are sometimes determined through internal investigations, external complaints, or FDA inspections. The following are the procedures to follow regardless of the manner in which the recalling firm is made aware of the issue with a supplement.
Determine whether or not the "issue" rises to the level of a recall.
Conduct an investigation, documenting everything, including a root cause analysis if possible.
Prepare a recall submission notification to your local FDA District Recall Coordinator including:
Codes (Product Identification numbers)
Firm Responsible for the Violation/Problem
Reason for Recall
Health Hazard Assessment
Volume of Recalled Product
Prepare Public Notification
Recall letters to supply chain
Conduct an evaluation of the Recall
Conduct an effectiveness of the recall assessment
Submit recall status reports on a monthly basis
Finalize and submit a root cause analysis
Finalize and submit a corrective action plan
Conduct an analysis for termination of recall