[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.40]
[Page 68-69]
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
Sec. Sec. 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
[[Page 69]]
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 ineffective, or discovers that a violation is continuing.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
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