FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
iven pursuant to section 705 of the Food, Drug, and Cosmetic Act]
1951-200O
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 direction of the
Federal Security Administrator.
MAURICE COLLINS, Acting Administrator, Federal Security Agency.
WASHINGTON, D. C, May 29,191ft.
CONTENTS*
Page
Drugs and devices actionable because of poten-
tial danger when used according to direc-
tions   
 251
Drugs actionable because of failure to bear ade-
quate directions or warning statements 253
Drug actionable because of the presence of a
habit-forming narcotic without warning
statement 
 258
Drugs actionable because of contamination with
filth 
 258
Page
Drug actionable because of the presence of a
noncertifled coal-tar color   259
Drugs and devices actionable because of devia-
tion from official or own standards  259
Drugs and devices actionable because of false
and misleading claims 
264
Drugs for human use 
 264
Drugs for veterinary use 
273
Drugs actionable because of omission of, or un-
satisfactory, ingredients statements 276
Index     277
DRUGS AND DEVICES ACTIONABLE BECAUSE OF POTENTIAL DANGER
WHEN USED ACCORDING TO DIRECTIONS
1951. Adulteration and. misbranding  of Livo-Plex.    U.  S.  v.  Vincent  Christina
and  Co.,   Inc., "and  Vincent   Christina.-   Pleas   of  guilty.    Fine,   $1,500.
(F. D. C. No. 15497.    Sample Nos. 53586-F, 53588-F, 58700-F.)
INFORMATION FILED: April 17, 1946, Southern District of New York, against
Vincent Christina and Co., Inc., New York, N. Y., and Vincent Christina, presi-
dent of the corporation.
ALLEGED SHIPMENT : On or about May 2 and June 1 and 19, 1944, from the State
of New York into the State of Maryland.
PRODUCT : IAvo-Plex. Bacteriological examination showed that the product was
contaminated with living micro-organisms.
LABEL, IN PART: "Vial 10 cc. Livo-Plex * * * For Intramuscular Use."
NATURE OF CHARGE : Adulteration, Section 501 (c), the quality and purity of the
article fell below that which it purported and was represented to possess. Its
labeling bore the statement "For Intramuscular Use," which implied that it
was an appropriate drug to be used for injection into the muscular tissues, a
use which requires a sterile product, whereas the article was unsterile and was
contaminated with viable micro-organisms.
Misbranding, Section 502 (j), the article would be dangerous to health when
used in the dosage suggested in the labeling, "Each 1 cc contains:    Injectable
* For failure to bear a label containing an accurate statement of the quantity of the contents, see Nos.
1955,1956,1962,1966,1978; failure to bear a label containing the name and place of business of the manu-
facturer, packer, or distributor, Nos. 1956,1962; cosmetic, actionable under the drug provisions of the Act,
No. 1978.
746608??47 1
 25
[D.D.N. J.
Liver 100 gms., Thiamine HCl (Bt) 10 mg., Riboflavin (B2) 0.1 mg., Pyridoxine
HC1 (Bo) 1 mg., Nicotinamide 10 mg., Calcium Pantothenate 0.1 mg., Phenol
0.5? For Intramuscular Use Caution: To be used only by or on the pre-
scription of a physician." The labeling suggested the injection of the
 article
into the muscular tissues in a dosage of 1 cc, or in a dosage appropriate for
intramuscular injection. The article when used as suggested would be dan-
gerous to health by reason of its contamination with viable micro-organisms.
DISPOSITION : April 30,1946. The defendants having entered pleas of guilty, the
court imposed a fine of $250, jointly and severally, on each of six counts, a total
fine of $1,500.
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