775. Adulteration and misbranding- of sodium caeod-ylate solution, alkaline com-
pound powder, oalcium jerluconate compound solution, diuretic wowder.
canine worm tablets, liauid nux vomica alkaloids, and tonic powder; and
misbranding: of Aresnol Compound Powder, glucose solution, potassium
arsenite compound tnblets. sahtrmin-ea^jiriel tablets, Guaiadine Tablets,
Conjunctivities #1 Tablets, and tetracWorethvlene capsules. U. S. v.
P?*erle?s Serum Co. Ple? of gui^+v. Fine, $!OK a**d costs. (F. P. O. No.
555. Sample Nos. 43057-F to 4305P-F. incl.. 43061-K 430R3-K to 43065-E
incl., 43067-E, 43069-E, 43074-E to 43076-E, incl., 43078-E, 43079-E.)   -
The labeling of these veterinary preparations, with the exception of the
potassium arsenite compound tablets, and the liquid nux vomica alkaloids, bore
false and misleading curative claims. Some of the products fell below their
own declared standards and others failed to comply with certain labeling re-
quirements of the law.
On March 28, 1942, the United States attorney for the District of Kansas filed
an information against the Peerless Serum Co., a corporation having a place of
business at Kansas City, Kans., alleging shipment within the period from on or
about August 16 to on or about October 25, 1940, from the State of Kansas into
the State of Oklahoma of quantities of the above-named veterinary preparations
which were misbranded and some of which were also adulterated.
Analysis of the sodium cacodylate solution showed that it contained not more
than 2.53 grains of sodium cacodylate per cc. It was alleged to be adulterated;
in that its strength differed from and its quality fell below that which it pur-
ported and was represented to possess, since it was represented to contain 4.5
grains of sodium cacodylate per cc.; whereas It contained not more than 2.53.
grains of sodium cacodylate per cc. It was alleged to be misbranded (1) in
that the statement on the bottle label, "Sodium Cacodylate Solution 4.5 Gr. per
cc." was false and misleading; (2) in that the statements on the bottle label,.
"Useful in the treatment of A'naplasmosis, Swamp Fever, Anemia, Influenza,'
Shipping Fever, Chronic Skin Diseases and to build up Convalescent Patients,"'
were false and misleading since it would not be efficacious for such purposes;
and (3) in that it contained sodium cacodylate, a derivative of arsenic, and its
label did not bear a statement showing the substance from which such ingredient
was derived.
Analysis of the alkaline compound powder showed that it consisted essentially
of sodium hydroxide with small proportions of copper sulfate, sodium thiosulfate,.
sodium bicarbonate, and phenol, and a minute amount of phenolphthalein flavored
with oil of anise. It was alleged to be adulterated in that it contained, for
purposes of coloring only, a coal-tar color, namely, phenolphthalein, other than
one from a batch that had been certified in accordance with regulations as pro-
vided by law. It was alleged to be misbranded in that the statements, "for the
treatment of necrotic enteritis * * * Action: Systemic Alkalinizer. Use:.
To rebuild Alkaline Reserve of bodily tissues and fluids; as an aid in the treat-
ment of Necrotic Enteritis (Swine) and Intestinal Infections of Poultry," borne
on the label, were false and misleading since it would not be efficacious for such
purposes.
Analysis of a sample of the Aresnol Compound Powder showed that it consisted
essentially of arsenic trioxide (1.02 percent), powdered willow bark, linseed meal,,
and sulfur. It was alleged to be misbranded (1) in that the statements, (box
label) "For the internal treatment of chronic supperative processes, such as
Fistulour Withers, Poll Evil, Grease Heel, Catarrhal, Respiratory, Uterine In-
fections, etc., of the Horse," were false and misleading since it would not he-
efficacious for such purposes; and (2) in that it was fabricated from two or more
ingredients and its label did not bear the common or usual name of each active
ingredient, including the quantity or proportion of arsenic that it contained.
Analysis of the calcium gluconate compound solution showed that it contained
approximately 15.05 percent of calcium gluconate and approximately 4 percent
of boric acid. It was alleged to be adulterated in that its strength differed from
and its quality fell below that which it purported and was represented to possess
in that it was represented to contain 23 percent of calcium gluconate; whereas
it contained not more than 15.05 percent of calcium gluconate. It was alleged to-
be misbranded (1) in that the statement (bottle label and carton) "Calcium.
Gluconate Comp. Solution * * * 23? Solution," was false and misleading;
(2) in that the statement (bottle label) "Indications: * * * azoturia," was
false and misleading since it would not be efficacious in the treatment of azoturia;
and (3) in that its labeling was misleading since it failed to reveal the fact,,
material in the light of the representations therein, that it contained boric acid.
Analysis of the Diuretic Powder showed that it contained approximately 2.61
percent of methenamine, also sodium bicarbonate, potassium nitrate, and plant
material including uva ursi, a resinous material, and an atropine-bearing drug;
such as belladonna. It was alleged to be adulterated in that its strength differed
from and its quality fell below that which it purported and was represented to
possess, since it was represented to contain 3 percent of methenamine; whereas
it contained not more than 2.61 percent of methenamine. It was alleged to be
misbranded (1) in that the statement, (carton label) "Contains Methenamine,
3?" was false and misleading; (2) in that the statement (carton) "Urinary-
disorders in horses, such as strangury, urinary retention associated with oedema
leading since it would not be efficacious for such purposes; and (3) in that it
was fabricated from two or more ingredients and contained the alkaloids of
atropine, hyoscine, and hyoscyamine, constituents of belladonna, but the label
?did not state the quantity or proportion of atropine, hyoscine, and hyoscyamine
present, nor did it state the quantity or proportion of total alkaloids contained as
constituents of belladonna.
Analysis of the Glucose Solution showed that it contained approximately 50
percent of anhydrous glucose. It was alleged to be misbranded in that the state-
ments, "For the treatment of eclampsia, auto-intoxication. Also of value in Milk
Fever * * * Adicosis * * * running fits and chronic diseases of a nerv-
ous nature," borne on the bottle label and carton, were false and misleading since
it would not be efficacious for such purposes.
Analysis of the Potassium Arsenite Compound tablets showed that each tablet
contained approximately 1.01 gram of arsenic as AS2O3 per tablet, and that each
tablet would make a solution containing not more than 0.854 gram of arsenic
trioxide in 100 cc. It was alleged to be misbranded in that the statement, "Each
tablet contains sufficient potassium arsenite to make four ounces of a solution
whose arsenic content is the same as that of Fowler's Solution," borne on the
bottle label, was false and misleading, since each tablet contained sufficient potas-
sium arsenite to make a solution containing in each 100 cc. not more than 0.854
gram of arsenic trioxide; whereas Fowler's solution is a drug the name of which
is recognized in the United States Pharmacopoeia, which provides that Fowler's
solution, namely, solution of potassium arsenite, shall contain in each 100 cc. the
equivalent of not less than 0.950 gram of As2Os, namely, arsenic trioxide.
Examination of the Canine Worm Tablets showed that the product consisted of
capsules, each capsule containing a red-coated tablet and gray powder. Analysis
showed that the tablets contained approximately 0.073 (1/14) grain of arecoline
each and that the powder consisted essentially of sodium bicarbonate, a small
proportion of santonin, and plant material including areca nut. The article was
alleged to be adulterated in that its strength differed from and its quality fell
below that which it purported and was represented to possess since each tablet
was represented to contain ?o grain of arecoline, whereas each tablet contained
not more than 0.073 (?4> grain of arecoline. It was alleged to be misbranded it!
that the statement (on the bottle label) "Tablets * * * Contains: Arecoline
* * * -W.0 gr-?" was false and misleading. It was alleged to be misbranded
further in that the statements (bottle label) "For Round * * * Worms in
dogs and cats" and "Worm," were false and misleading since it would not be
efficacious for such purposes.
Analysis of the Santonin-Calomel tablets showed that they contained santonin
and calomel in approximately* the quantities declared on the label, namely,
"Calomel ? Gr. Santonin ? Gr." The article was alleged to be misbranded (1)
in that the statement on the bottle label "Round worms in dogs and cats," was
false and misleading since it would not be efficacious for such purposes; (2) in
that it was fabricated from two or more" ingredients and contained calomel, a
derivative of mercury, but the label did not bear a statement showing that said
ingredient was derived from mercury; and (3) in that the statement on the bottle
label "Each cc. contains a quarter "grain each of strychnine Sulphate and Brucine
Sulphate," was false and misleading.
The Tetrachlorethylene Capsules were alleged to be misbranded in that the
statement on the bottle label, "For the removal of * * * round worms from
all animals," was false and misleading since they would not be efficacious for
such purposes.
Analysis of the Tonic Powder showed that it contained not more than 22 percent
of phosphate and that it contained arsenic trioxide, sodium sulfate, iron sulfate,
a calcium compound, and plant material including nux vomica, gentian, and
quassia. It was alleged to be adulterated in that its strength differed from and
its quality fell below that which it purported and was represented to possess,
since it was represented to contain 28 percent of phosphate, whereas it contained
not more than 22 percent of phosphate. It was alleged to be misbranded (1) in
that the statements on the cartons, "1 Pound" and "Contains * * ' * Phos-
phate, 28?," were false and misleading since each of the cartons contained less
than 1 pound of the powder and less than 28 percent of phosphate; (2) in that
the statements on the cartons, "restorative. * * * improves digestion and
assimilation of food," were false and misleading since it would not be efficacious
for such purposes; (3) in that it was fabricated from two or more ingredients
and contained strychnine; and (4) in that its container (bottle) was so filled as
to be misleading since the contents occupied not more than 30 percent of its total
volume.
Analysis of the Guaiadine Tablets showed that they contained small proportions
of potassium dichromate-, iodine, guiacol, and creosote. The article was alleged
to be misbranded in that the statements on the bottle label, "Indications: In the
treatment of the so-called Fowl Cholera, Typhoid, Roup, Coccidosis and various
troubles originating in the intestinal tract of fowls," were false and misleading
since it would not be efficacious for such purposes.
Analysis, of the Conjunctivitis #1 Tablets showed that they contained boric
acid, zinc sulfate, salicylic acid, and methylene blue. They were alleged to be
misbranded in that the statement "Conjunctivitis," borne on the bottle label, was
false and misleading since they would not be efficacious in the treatment of
conjunctivitis.
Analysis of the Liquid Nux Vomica Alkaloids showed that the article contained
not mare than 0.1508 (slightly less than ?) grain of strychnine sulfate and 0.0441
(1/23) grain, of brucine sulfate, per cc. It was alleged to be adulterated in that
its strength differed from and its quality fell below that which it purported and
was represented to possess, since it was represented to contain ? grain of strych-
nine sulfate and ? grain of brucine sulfate per cc.; whereas it contained not
more than.0.1503 (slightly less than ?) grain of strychnine sulfate and not more
than 0.0441 (1/230 grain of brucine sulfate per cc. It was alleged to be con-
stituent of the drug nux vomica, but its label failed to declare the quantity of
strychnine that it contained.
On April 13, 1942, a plea of guilty was entered on behalf of the defendant and
the court imposed a fine of $105 and costs.