What should the firm do to initiate a recall? (Firm-initiated recall)

The following information must be provided to the FDA for recall notification:
[21 CFR 7.46(a)]

1. Identify the product involved.

2. Give reason for the removal or correction. State the date and circumstance in which the hazard or product deficiency is discovered.

3. Evaluation of the risk associated with the hazard or deficiency.

4. Total amount of such product being manufactured and/or the timespan of production.

5. Total amount of product being distributed

6. Distribution information which include number of direct accounts and the identity of accounts, if necessary.

7. A copy of the firm’s recall communication if any has issued, or a proposed communication if it has yet issue.

8. Proposed recall strategy

9. Name and telephone number of the firm official who should be contacted concerning the recall.


Food and Drugs Administration Department of Health and Human Services. (2007). Title 21-Food and Drugs Chapter 1. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=7.46. Accessed on: 5 April, 2008.