Recalling firm

The recalling firm carries the duties of running the recall, informing consignees and reporting progress to FDA. When a contract manufacturer and a brand owner are both involved, their agreement should say in advance who takes this role.

Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.

21 CFR, 7.3