[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: 21CFR7.46]

[Page 70-71]
 
                        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.  7.46  Firm-initiated recall.

    (a) A firm may decide of its own volition and under any 
circumstances to

[[Page 71]]

remove or correct a distributed product. A firm that does so because it 
believes the product to be violative is requested to notify immediately 
the appropriate Food and Drug Administration district office listed in 
Sec.  5.115 of this chapter. Such removal or correction will be 
considered a recall only if the Food and Drug Administration regards the 
product as involving a violation that is subject to legal action, e.g., 
seizure. In such cases, the firm will be asked to provide the Food and 
Drug Administration the following information:
    (1) Identity of the product involved.
    (2) Reason for the removal or correction and the date and 
circumstances under which the product deficiency or possible deficiency 
was discovered.
    (3) Evaluation of the risk associated with the deficiency or 
possible deficiency.
    (4) Total amount of such products produced and/or the timespan of 
the production.
    (5) Total amount of such products estimated to be in distribution 
channels.
    (6) Distribution information, including the number of direct 
accounts and, where necessary, the identity of the direct accounts.
    (7) A copy of the firm's recall communication if any has issued, or 
a proposed communication if none has issued.
    (8) Proposed strategy for conducting the recall.
    (9) Name and telephone number of the firm official who should be 
contacted concerning the recall.
    (b) The Food and Drug Administration will review the information 
submitted, advise the firm of the assigned recall classification, 
recommend any appropriate changes in the firm's strategy for the recall, 
and advise the firm that its recall will be placed in the weekly FDA 
Enforcement Report. Pending this review, the firm need not delay 
initiation of its product removal or correction.
    (c) A firm may decide to recall a product when informed by the Food 
and Drug Administration that the agency has determined that the product 
in question violates the law, but the agency has not specifically 
requested a recall. The firm's action also is considered a firm-
initiated recall and is subject to paragraphs (a) and (b) of this 
section.
    (d) A firm that initiates a removal or correction of its product 
which the firm believes is a market withdrawal should consult with the 
appropriate Food and Drug Administration district office when the reason 
for the removal or correction is not obvious or clearly understood but 
where it is apparent, e.g., because of complaints or adverse reactions 
regarding the product, that the product is deficient in some respect. In 
such cases, the Food and Drug Administration will assist the firm in 
determining the exact nature of the problem.