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]
4121-4140 
-        -Y
DRUGS AND DEVICES 
O"      '
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the
Department of Health, Education, and Welfare, and include, where indicated,
the results of investigations by the Department, prior to the institution of the
proceedings. Published by direction of the Secretary of Health, Education, and
Welfare.
CHARLES W. CRAWFORD, Commissioner of Food and Drugs.
WASHINGTON, D. C, May 26,195?.
Page
Drug actionable because of poten-
tial danger when used accord-
ing to directions
120
Violative    sales    of    prescription
drugs
120
Drugs actionable because of failure
to bear adequate*directions or
warning statements
121
CONTENTS*
Face
Drugs actionable because of devia-
tion    from    official    or    own
standards 
124
Drugs actionable because of false
and misleading claims 
127
Drugs for human use 
127
Drug for veterinary use 
136
Index_._J 
137
*For omission of, or unsatisfactory, ingredients statements, see Nos. 4125, 4128, 4131, 4138,
4140; failure to bear a label containing an accurate statement of the quantity of the contents,
Nos. 4125, 4126, 4131; failure to bear a label containing the name and place of business of the
manufacturer, packer, or distributor, Nos. 4126, 4128, 4131; labeling information not likely to
be read and understood by the ordinary individual under customary conditions of purchase and
use, No. 4130.
119
297270-54 1
DRUG ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DHtECTIONS
4121. Misbranding of Isopto Alkaline.   U. S. v. 26 Cartoned Bottles * * *.
(F. D. C. No. 34907.   Sample No. 67271-L.)
LIBEL FILED : March 20,1953, Eastern District of Louisiana.
ALLEGED SHIPMENT : On or about December 26,1952, by Alcon Laboratories, Inc.,
from Fort Worth, Tex.
PRODUCT : 26 cartoned bottles of Isopto Alkaline at New Orleans, La. Examina-
tion showed that the product was contaminated with Pseudomonas aeruginosa.
LABEL, IN PART : (Bottle) "15 cc. Isopto Alkaline Alcon Brand Of Physiologic
Methyl Cellulose Ophthalmic 1? with Benzalkonium Chloride 1:50,000 in
saline solution INDICATIONS: As a vehicle for Ophthalmic drugs, which
are stable in an alkaline (pH 7.4) menstruum. Directions: One to two drops
in eye(s) three times daily, or as directed by Physician."
NATUKE OF CHARGE: Misbranding, Section 502 (j), the article was dangerous to
health when used in the dosage and with the frequency prescribed, recom-
mended, and suggested in its labeling, namely, as a vehicle for ophthalmic
drugs, used 3 times daily.
DISPOSITION :   May 4, 1953.   Default decree of condemnation and destruction.
VIOLATIVE SALES OF PRESCRIPTION DRUGS