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FDA/IAS* Brochure: 1994
FDA Recall Policies
(This brochure provides a discussion of the policies of the Food
and Drug Administration and the procedures that are to be used by
firms in conducting recalls of violative products that are
regulated by the Agency)
The recall of a defective or possibly harmful consumer product
often is highly publicized in newspapers and on news broadcasts.
This is especially true when a recall involves foods, drugs,
cosmetics, medical devices, and other products regulated by FDA.
Despite this publicity, FDA's role in conducting a recall often is
misunderstood not only by consumers, but also by the news media,
and occasionally even by the regulated industry. The following
headlines, which appeared in two major daily newspapers, are good
examples of that misunderstanding: "FDA Orders Peanut Butter
Recall," and "FDA Orders 6,500 Cases of Red-Dyed Mints Recalled."
The headlines are wrong in indicating that the Agency can "order"
a recall. FDA has no authority under the Federal Food, Drug, and
Cosmetic Act to order a recall, although it can request a firm to
recall a product.
Most recalls of products regulated by FDA are carried out
voluntarily by the manufacturers or distributors of the product. In
some instances, a company discovers that one of its products is
defective and recalls it entirely on its own. In others, FDA
informs a company of findings that one of its products is defective
and suggests or requests a recall. Usually, the company will
comply; if it does not, then FDA can seek a court order authorizing
the Federal Government to seize the product.
This cooperation between FDA and its regulated industries has
proven over the years to be the quickest and most reliable method
to remove potentially dangerous products from the market. This
method has been successful because it is in the interest of FDA, as
well as industry, to get unsafe and defective products out of
consumer hands as soon as possible.
FDA has guidelines for companies to follow in recalling defective
products that fall under the Agency's jurisdiction. These
guidelines make clear that FDA expects these firms to take full
responsibility for product recalls, including follow-up checks to
assure that recalls are successful.
Under the guidelines, companies are expected to notify FDA when
recalls are started, to make progress reports to FDA on recalls,
and to undertake recalls when asked to do so by the Agency.
The guidelines also call on manufacturers and distributors to
develop contingency plans for product recalls that can be put into
effect if and when needed. FDA's role under the guidelines is to
monitor company recalls and assess the adequacy of a firm's action.
After a recall is completed, FDA makes sure that the product is
destroyed or suitably reconditioned and investigates why the
product was defective.
The guidelines categorize all recalls into one of three classes
according to the level of hazard involved. Class I recalls are for
dangerous or defective products that predictably could cause
serious health problems or death. Examples of products that could
fall into this category are a food found to contain botulinal
toxin, a label mix-up on a lifesaving drug, or a defective
artificial heart valve.
Class II recalls are for products that might cause a temporary
health problem, or pose only a slight threat of a serious nature.
One example is a drug that is understrength but that is not used to
treat life-threatening situations.
Class III recalls are for products that are unlikely to cause any
adverse health reaction, but that violate FDA regulations. An
example might be bottles of aspirin that contains 90 tablets
instead of the 100 stated on the label.
FDA develops a strategy for each individual recall that sets forth
how extensively it will check on a company's performance in
recalling the product in question. For a Class I recall, for
example, FDA would check to make sure that each defective product
has been recalled or reconditioned. In contrast, for a Class III
recall the Agency may decide that it only needs to spot check to
make sure the product is off the market.
Even though the firm recalling the product may issue a press
release, FDA seeks publicity about a recall only when it believes
the public needs to be alerted about a serious hazard. For example,
if a canned food product, purchased by a consumer at a retail
store, is found by FDA to contain botulinal toxin, an effort would
be made to retrieve all the cans in circulation, including those in
the hands of consumers. As part of this effort the Agency also
could issue a public warning via the news media to alert as many
consumers as possible to the potential hazard.
FDA also issues general information about all new recalls it is
monitoring through a weekly publication (FDA Enforcement Report)
which is available for purchase from the Government Printing
Office, Washington, DC 20402, Telephone 202-783-3238.
For additional linformation on recalls, contact the FDA District
Office nearest you. District Offices are listed on the following
pages.
+++++++++++++++++++++++++++
Eastern States
MA, ME, NH, VT, RI, CT
One Montvale Ave.
Stoneham, MA 02180-3542
(617) 279-1476
NY
850 Third Ave.
Brooklyn, NY 11232-1593
(718) 965-5301
or
599 Delaware Ave.
Buffalo, NY 14202
(716) 846-4478
NJ
61 Main St.
West Orange, NJ 07052
(201) 645-3023
PA, DE
U.S. Customhouse
Rm. 900
2nd & Chestnut Sts.
Philadelphia, PA 19106
(215) 597-4390
MD, DC, VA, WV
900 Madison Ave.
Baltimore, MD 21201
(301) 962-4012
GA, NC, SC
60 Eighth St., NE
Atlanta, GA 30309
(404) 347-4344
FL
7200 Lake Ellenor Dr.
Suite 120
Orlando, FL 32809
(407) 648-6995
PR
P.O. Box 5719
Puerta de Tierra Station
San Juan, PR 00906-5719
(809) 729-6884
Middle States
MI, IN
1560 East Jefferson Ave.
Detroit, Ml 48207
(313) 226-6260
MN, WI, ND, SD
240 Hennepin Ave.
Minneapolis, MN 55401-1999
(612) 334-4102
IL
Post Office Bldg.
Rm. 1222
433 West Van Buren St.
Chicago, IL 60607
(312) 353-7379
OH, KY
1141 Central Parkway
Cincinnati, OH 45202-1097
(513) 684-3504
KS, IA, NE, MO
1009 Cherry St.
Kansas City, MO 64106
(816) 374-6373
(After June, 1992
11510 West 80th St.
Lenexa, KS 66215)
TN, AL
297 Plus Park Blvd.
Nashville, TN 37217
(615) 736-7222
LA, MS
4298 Elysian Fields Ave.
New Orleans, LA 70122
(504) 589-2401
TX, AR, OK
3032 Bryan St.
Dallas, TX 75204-6191
(214) 655-5315
CO, WY, UT, NM
Denver Federal Center, Bldg. 20
P.O. Box 25087
Denver, CO 80225-0087
(303) 236-3017
Western States
WA, OR, MT, ID, AK
P.O. Box 3012
22201 23rd Dr., S.E.
Bothell, WA 98041-3012
(206) 483-4950
CA (Northern), NV, HI
Federal Office Bldg.
Rm 506
50 U.N. Plaza
San Francisco, CA 94102
(415) 556-0318
CA (Southern), AZ
1521 West Pico Blvd.
Los Angeles, CA 90015-2486
(213) 252-7586
*FDA/Industry Affairs Staff Brochure: 1994