FOOD AND DRUG ADMINISTRATION MK
    r
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3821-3840
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.    Published by direction of the Federal Security Administrator.
CHABLES W. CBAWFOBD, Commissioner of Food and Drugs,
WASHINGTON, D. C, March 16,1953.
CONTENTS *
Page
Drugs in violation of prescription
labeling lequirements 
312
Drugs actionable because of failure
to bear adequate directions or
warning statements 
312
Drugs and devices actionable
because of deviation from
official or own standards 318
Page
Drugs actionable because of false
and misleading claims 
322
Drugs for human use 
 322
Drugs for veterinary use 
324
Index 
326-
*For presence of a habit-forming narcotic without warning statement, see Nos. 3822-3824, 3826-3828";
omission of, or unsatisfactory, ingredients statements, Nos. 3822-3826; imitation of, and sale under name of,
another drug, No. 3830; failure to bear a label containing an accurate statement of the quantity of the con-
tents, Nos. 3822-3828; failure to bear a label containing the name and place of business of the manufacturer,
packer, or distributor, Nos. 3822-3827.
311
242335-53 1
DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS
3821. Misbranding of male hormone tablets.   U. S. y. 719 Boxes, etc.    (F. D. C.
No. 33331.    Sample Nos. 34692-L, 34693-L.)
July 19, 1952, Western District of Arkansas.
?MENT;    On or about May 29, 1952, by Captivante Laboratories,
from NW^ork, N. Y.
PRODUCT :    l,3TT^60-tablet boxes of male hormone tablets at Hot Springs, Ark.
LABEL, IN PART4 (Box) "Yale Testrex Male Sex Hormones 60 Tablets
* * . * Ingredients per tablet 2.5 mg. Metbyl Testosterone witb Ethinyl
Estradiol .0025 mg." and "Yale Testrex Male Sex Hormones 60 Tablets-
Super-Strength (Double Potency) * * * Ingredients per tablet 5 mg.
Methyl Testosterone with Ethinyl Estradiol .0050 mg."
NATURE OF CHARGE: Misbranding, Section 503 (b) (4), the tablets were in-
tended for use by man and were subject to Section 503 (b) (1) (B), and the
labels of the tablets failed to bear the statement "Caution: Federal Law
prohibits dispensing without prescription."
DISPOSITION : September 23, 1952. Default decree of condemnation and de-
struction.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS