[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.250]

[Page 203-204]
 
                        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.  107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the recall to the appropriate Food and Drug Administration district 
office listed in part 5, subpart M of this chapter for transmittal to 
the Center for Food Safety and Applied Nutrition (HFS-605), for action. 
Any such recommendation shall contain information supporting a 
conclusion that the recall strategy has been effective. The agency will 
respond within 15 days of receipt by the Center for Food Safety and 
Applied Nutrition (HFS-605), of the request for termination. The 
recalling firm shall continue to implement the recall strategy until it 
receives final written notification from the agency that the recall has 
been terminated.

[[Page 204]]

The agency will send such a notification unless it has information, from 
FDA's own audits or from other sources, demonstrating that the recall 
has not been effective. The agency may conclude that a recall has not 
been effective if:
    (a) The recalling firm's distributors have failed to retrieve the 
recalled infant formula; or
    (b) Stocks of the recalled infant formula remain in distribution 
channels that are not in direct control of the recalling firm.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004]