[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: 21CFR7.49]

[Page 71-72]
 
                        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.  7.49  Recall communications.

    (a) General. A recalling firm is responsible for promptly notifying 
each of its affected direct accounts about the recall. The format, 
content, and extent of a recall communication should be commensurate 
with the hazard of the product being recalled and the strategy developed 
for that recall. In general terms, the purpose of a recall communication 
is to convey:
    (1) That the product in question is subject to a recall.
    (2) That further distribution or use of any remaining product should 
cease immediately.
    (3) Where appropriate, that the direct account should in turn notify 
its customers who received the product about the recall.
    (4) Instructions regarding what to do with the product.
    (b) Implementation. A recall communication can be accomplished by 
telegrams, mailgrams, or first class letters conspicuously marked, 
preferably in bold red type, on the letter and the envelope: ``drug [or 
food, biologic, etc.] recall [or correction]''. The letter and the 
envelope should be also marked: ``urgent'' for class I and class II 
recalls and, when appropriate, for class III recalls. Telephone calls or 
other personal contacts should ordinarily be confirmed by one of the 
above methods and/or documented in an appropriate manner.
    (c) Contents. (1) A recall communication should be written in 
accordance with the following guidelines:

[[Page 72]]

    (i) Be brief and to the point;
    (ii) Identify clearly the product, size, lot number(s), code(s) or 
serial number(s) and any other pertinent descriptive information to 
enable accurate and immediate identification of the product;
    (iii) Explain concisely the reason for the recall and the hazard 
involved, if any;
    (iv) Provide specific instructions on what should be done with 
respect to the recalled products; and
    (v) Provide a ready means for the recipient of the communication to 
report to the recalling firm whether it has any of the product, e.g., by 
sending a postage-paid, self-addressed postcard or by allowing the 
recipient to place a collect call to the recalling firm.
    (2) The recall communication should not contain irrelevant 
qualifications, promotional materials, or any other statement that may 
detract from the message. Where necessary, followup communications 
should be sent to those who fail to respond to the initial recall 
communication.
    (d) Responsibility of recipient. Consignees that receive a recall 
communication should immediately carry out the instructions set forth by 
the recalling firm and, where necessary, extend the recall to its 
consignees in accordance with paragraphs (b) and (c) of this section.