[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.250]

[Page 197-198]
 
                        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 Sec. 5.215 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. 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:

[[Page 198]]

    (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]