FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3741-3760
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the
Federal Security Agency, and include, where indicated, the results of investi-
gations by the Agency, prior to the institution, of the proceedings. Published by
direction of the Federal Security Administrator.
CHARLES W. CRAWFORD, Commissioner of Food and Drugs.
WASHINGTON, D. C, November 12, 1952.
CONTENTS*
Page
Device actionable because of po-
tential danger when used ac-
cording to directions 
234
New drug shipped without effective
application 
235
Drugs actionable because of failure
to bear adequate directions or
warning statements 
235
Page
Drugs actionable because of devia-
tion    from    official    or    own
standards 
241
Drugs actionable because of false
and misleading claims 
244
Drugs for human use 
244
Drugs for veterinary use 
246
Index 
249
*For presence of a habit-forming narcotic without warning statement, see Nos. 3743-3746; omission of, or
unsatisfactory, ingredients statements, No. 3746; failure to bear a label containing an accurate statement of
the quantity of the contents, Nos. 3743, 3745, 3746; failure to bear a label containing the name and place of
business of the manufacturer, packer, or distributor, Nos. 3744, 3745; labeling information not likely to-be
read and understood by the ordinary individual under customary conditions of purchase and use, No. 3757.
S20781-52-
233
DEVICE ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
3741. Misbranding of RecTone devices.   U. S. v. 9 Cartons, etc    (F. D. C. No.   [
32156.   Sample No. 16377-L.)
LIBEL FILED :   November 29,1951, Western District of Missouri.
ALLEGED SHIPMENT: On or about June 6 and October 4 and 16, 1951, by the
Walker-Young Corp., from Long Beacb, Calif.
PRODUCT: RecTone devices. 9 cartons, each carton containing 1 rubber bulb
air pump with hose and 10 RecTone medicators, with some of the cartons con-
taining a leaflet printed in blue ink and other cartons containing a leaflet
printed in black ink, both entitled "RecTone The Method of Humane Rectal
Therapy," and one carton containing a leaflet entitled "Reference Manual,"
at Kansas City, Mo. In addition to the 9 cartons, there were 3 cartons, each
containing 10 RecTone medicators and one of the leaflets entitled "Rec-
Tone  *   *   *"  in blue or black ink, also at Kansas City, Mo.
Each RecTone medicator was inclosed in a cellophane envelope and con-
sisted of a cylindrical, elastic, finger-like bag closed at one end and having an
open tube at the other for attaching to the air pump. The medicators were
approximately 5 inches long and between ? inch and ? inch in maximum
diameter.
LABEL, IN PAST: (Cellophane envelope) "RecTone Medicator The Medica-
ment Herein Contains: Benzocain 4? Phenol 0.5? Boric Acid, Bismuth
Subnitrate, Resorcin 0.5? Balsam Peru, Zinc Oxide and Aquaphor Water
Soluble Base."
NATURE OF CHARGE: Misbranding, Section 502 (j), the article was dangerous to
health when used as suggested in its labeling, namely, by inserting into the
rectum and inflating.
Further misbranding, Section 502 (a), certain statements in the labeling of
the article, namely, in the above-mentioned leaflets, were false and misleading.
The statements represented and suggested that the article was an effective
treatment for piles; for restoring rectal health and a sense of well-being to the
individual; for hemorrhoids; for bleeding, itching, or burning conditions of
the anal canal; for stricture of the anal canal; for destroying infection and
reviving fresh blood circulation in the strangulated hemorrhoidal vein system,
thus enabling the natural healing powers of the blood to operate in releasing
nerve tension and mending ailing tissue; for chronic conditions of the anal
tract; for retoning rectal nerves and muscles; for enabling the all-important
sphincter muscles to become pliable and strong and resume their normal func-
tion ; and for controlling scar tissue and speeding up the healing process follow-
ing surgery. The article was not an effective treatment for such conditions,
and it was not capable of fulfilling the promises of benefit made for it.
DISPOSITION: January 22, 1952. Default decree of condemnation. The court
ordered that the product be delivered to the Food and Drug Administration.
NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION