[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.210]

[Page 197]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 107_INFANT FORMULA--Table of Contents
 
                    Subpart E_Infant Formula Recalls
 
Sec.  107.210  Firm-initiated product removals.

    (a) If a manufacturer has determined to recall voluntarily from the 
market an infant formula that is not subject to Sec.  107.200 but that 
otherwise violates the laws and regulations administered by the Food and 
Drug Administration (FDA) and that would be subject to legal action, the 
manufacturer, upon prompt notification to FDA, shall administer such 
voluntary recall consistent with the requirements of this subpart.
    (b) If a manufacturer has determined to withdraw voluntarily from 
the market an infant formula that is adulterated or misbranded in only a 
minor way and that would not be subject to legal action, such removal 
from the market is deemed to be a market withdrawal, as defined in Sec.  
7.3(j) of this chapter. As required by Sec.  107.240(a), the 
manufacturer shall promptly notify FDA of such violative formula and 
may, but is not required to, conduct such market withdrawal consistent 
with the requirements of this subpart pertaining to product recalls.

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