[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: 21CFR7.50]

[Page 72]
 
                        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.  7.50  Public notification of recall.

    The Food and Drug Administration will promptly make available to the 
public in the weekly FDA Enforcement Report a descriptive listing of 
each new recall according to its classification, whether it was Food and 
Drug Administration-requested or firm-initiated, and the specific action 
being taken by the recalling firm. The Food and Drug Administration will 
intentionally delay public notification of recalls of certain drugs and 
devices where the agency determines that public notification may cause 
unnecessary and harmful anxiety in patients and that initial 
consultation between patients and their physicians is essential. The 
report will not include a firm's product removals or corrections which 
the agency determines to be market withdrawals or stock recoveries. The 
report, which also includes other Food and Drug Administration 
regulatory actions, e.g., seizures that were effected and injunctions 
and prosecutions that were filed, is available upon request from the 
Office of Public Affairs (HFI-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.