[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.45]

[Page 81]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 7--ENFORCEMENT POLICY--Table of Contents
 
Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, 
                Procedures, and Industry Responsibilities
 
Sec. 7.45  Food and Drug Administration-requested recall.

    (a) The Commissioner of Food and Drugs or his designee under 
Sec. 5.20 of this chapter may request a firm to initiate a recall when 
the following determinations have been made:
    (1) That a product that has been distributed presents a risk of 
illness or injury or gross consumer deception.
    (2) That the firm has not initiated a recall of the product.
    (3) That an agency action is necessary to protect the public health 
and welfare.
    (b) The Commissioner or his designee will notify the firm of this 
determination and of the need to begin immediately a recall of the 
product. Such notification will be by letter or telegram to a 
responsible official of the firm, but may be preceded by oral 
communication or by a visit from an authorized representative of the 
local Food and Drug Administration district office, with formal, written 
confirmation from the Commissioner or his designee afterward. The 
notification will specify the violation, the health hazard 
classification of the violative product, the recall strategy, and other 
appropriate instructions for conducting the recall.
    (c) Upon receipt of a request to recall, the firm may be asked to 
provide the Food and Drug Administration any or all of the information 
listed in Sec. 7.46(a). The firm, upon agreeing to the recall request, 
may also provide other information relevant to the agency's 
determination of the need for the recall or how the recall should be 
conducted.