[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.40]

[Page 74-75]
 
                        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. 7.40  Recall policy.

    Source: 43 FR 26218, June 16, 1978, unless otherwise noted.


    (a) Recall is an effective method of removing or correcting consumer 
products that are in violation of laws administered by the Food and Drug 
Administration. Recall is a voluntary action that takes place because 
manufacturers and distributors carry out their responsibility to protect 
the public health and well-being from products that present a risk of 
injury or gross deception or are otherwise defective. This section and 
Secs. 7.41 through 7.59 recognize the voluntary nature of recall by 
providing guidance so that responsible firms may effectively discharge 
their recall responsibilities. These sections also recognize that recall 
is an alternative to a Food and Drug Administration-initiated court 
action for removing or correcting violative, distributed products by 
setting forth specific recall procedures for the Food and Drug 
Administration to monitor recalls and assess the adequacy of a firm's 
efforts in recall.
    (b) Recall may be undertaken voluntarily and at any time by 
manufacturers and distributors, or at the request of the Food and Drug 
Administration. A request by the Food and Drug Administration that a 
firm recall a product is reserved for urgent situations and is to be 
directed to the firm that has primary responsibility for the manufacture 
and marketing of the product that is to be recalled.
    (c) Recall is generally more appropriate and affords better 
protection for consumers than seizure, when many lots of product have 
been widely distributed. Seizure, multiple seizure, or other court 
action is indicated when a firm refuses to undertake a recall requested 
by the Food and Drug Administration, or where the agency has reason to 
believe that a recall would not be effective, determines that a recall 
is

[[Page 75]]

ineffective, or discovers that a violation is continuing.

[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]