FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
I Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
2001-2050
DRUGS AND DEVICES
The eases reported herewith were instituted in the United States district courts
by the United States attorneys acting upon reports submitted by direction of the
Federal Security Administrator.
MAURICE COLLINS, Acting Administrator, Federal Security Agency,
WASHINGTON, D. C, June 5,1941.
Page
Drug actionable because of potential danger
when used according to directions      281
Drug requiring certificate or release, for which
none had been issued 
    282
Drugs actionable because of failure to bear ade-
quate directions or warning statements...     282
Drugs actionable because of contamination
with filth 
     287
Drug actionable because of the presence of a
noncertified coal-tar color 
     288
CONTENTS*
Page
Drugs and devices "actionable because of devi-
ation from official or own standards.     289
Drugs and devices actionable because of false
and misleading claims.       294
Drugs for human use        294
Drugs for veterinary use .' 
-    301
Drugs actionable because of failure to bear ac-
curate statements of the quantity of the
contents.. 
    305
Index 
._     306
DRUG ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
2O01. Misbranding of Anademin Tablets.    TJ. S. v. 52 Packages and 5 Packages
of Anademin Tablets.    Default decree of condemnation and destruction.
(F. D. C. No. 20102.   Sample No. 14079-H.)
LIBEL FILED :    June 26, 1946, Southern District of Ohio.
ALLEGED SHIPMENT : On or about October 30,1945, and April 8 and May 29,1946,
by the Anademin Chemical Co., from Chattanooga, Tenn.
PRODUCT: 52 lOO-t&blet packages and 5 500-tablet packages of Anademin
Tablets at Cincinnati, Ohio. Assay by the method described in. the Twelfth
Revision of the United States Pharmacopoeia showed that each tablet of the
product had a potency of 3.17 U. S. P. Digitalis Units.
LABEL, IN PAST: "100 [or "500"] 5 grain Tablets Anademin * * * Cau-
tion : To be used only by or on the prescription of a physician. Assay: As
assayed by the method described in U. S. P. XII for Digitalis, each tablet has a
potency of 1.25 U. S. P. Digitalis units."
^For omission of, or unsatisfactory, ingredients statements, see Nos. 2003, 2005, 2008, 2031, 2034, 2035, 2046;
failure to comply with the packaging requirements of an official compendium. No. 2028; failure to bear a label
containing the name and place of business of the manufacturer, packer, or distributor, Nos. 2003, 2028.
747146??47 1
 28
NATURE OF CHARGE:   Misbranding, Section 502 (a), the label statement-"As
assayed by the method described in U. S. P. XII for Digitalis, each tablfft has  f
a potency of 1.25 U. S. P. Digitalis units," was false and misleading since tft^Lk
potency of the article as indicated by* the method described in the TwelftlFlJ
Revision of the United States Pharmacopoeia was materially in excess of 1.25 -
U. S. P. Digitalis Units; and, Section 502 (j), the article was dangerous to
health when used in the dosage suggested by the statement quoted above, since,
if prescribed by a physician in reliance upon such statement of potency, the
patient would receive an excessive amount of a potent drug.
DISPOSITION : August 9, 1946. No claimant having appeared, judgment of con-
demnation was entered and the product was ordered destroyed.
DRUG REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD
BEEN ISSUED