756. Adulteration of triple distilled water and sterile  solution of epinephrine
chloride; misbranding of Suppletive Formula No. 1, Sterile Supportive
Formula S. G. M. a., Sterile Solution Formula No. 1, Compressed Tablets
No. 358, and Compressed Tablets Thyroid; adulteration and misbranding
of Neohormestrin,^ solution of quinine and urea hydrochloride, quinine
sulfate tablets, and sterile solution of ovarian extract. IT; S. v. E. S.
Miller Laboratories, Inc. Plea of nolo contendere. Fine, $75 on each of
4 counts. Imposition of sentence suspended on remaining counts and
defendant placed on probation for 1 year. (F. D. C. No. 4132. Sample
Nos. 7368-E, 7397-E, 7655-E, 7939-E, 30843-E, 31909-E, 31912-E, 32631-E.
53828-E to 53831-E. incl., 53833-E, 55734-E.)
This case involved the following violations and products: Failure to bear
adequate directions, adequate warning statements, and satisfactory ingredient
statements, Suppletive Formula No. 1 and Sterile Solution No. 1; failure to
bear adequate directions and warnings, Compressed Tablets No. 358 and Com-
pressed Tablets Thyroid; failure to bear adequate directions and ingredient
statements, Sterile Supportive Formula S. G. M. a.; failure to comply with own
standard of strength and quality and to bear satisfactory ingredient state-
ment, Neohormestrin; failure to comply with official standard and reduction
of quality because of the presence of minute particles of rubber, triple distilled
water; failure to comply with official standards of strength and quality, qui-
nine and urea hydrochloride, quinine sulfate, and epinephrine chloride.
8 See also Nos. 754, 755.
533413-43 2
On February 16, 1942, the United States attorney for the Southern District
of California filed an information against E. S. Miller Laboratories, Inc., Los
Angeles, Calif., alleging shipment within the period from on or about April
30, 1940, to on or about March 28, 1941, from the State of California into the
States of Arizona, Illinois, and Oregon of quantities of the above-named drugs
which were adulterated and/or misbranded.
The Suppletive Formula No. 1 was alleged to be misbranded in that its labeling
failed to bear (1) adequate directions for use; and (2) adequate warnings
against use in those pathological conditions where its use might be dangerous to
health or against unsafe dosage or methods or duration of administration in
such manner and form as are necessary for the protection of users since it con-
tained emetine hydrochloride, and warnings that its use might cause vomiting,
nausea, heart, kidney, stomach, or intestinal injury or disease unless adminis-
tered in restricted dosage by a physician; and that it should not be administered
over a continued period of time because of its cumulative toxic effects. It was al-
leged to be misbranded further in that its label did not bear the common or usual
name of the drug contained therein, i. e., emetine hydrochloride.
The Sterile Solution Formula No. 1 was alleged to be misbranded in that its
label failed to bear adequate directions for use and adequate warnings against use
in those pathological conditions where its use might be dangerous to health, or
against unsafe dosage or methods or duration of administration since it con-
tained emetine and its labeling failed to bear warnings that its use might cause
nausea, vomiting, heart, kidney, stomach, or intestinal diseases, that it should
not be used in the presence of such pathological conditions; and that it might be
especially dangerous for elderly persons and should not be administered to
individuals suffering from high blood pressure, heart disease, diabetes, or thyroid
trouble except when administered by a physician. It was alleged to be misbranded
further in that it was fabricated from two or more ingredients and its label failed
to bear the common or usual name of each active ingredient.
The Compressed Tablets No. 358 were alleged to be misbranded in that the
labeling did not bear adequate directions for use since it bore no directions at
all; and in that it failed to,bear adequate warnings against use in those pathologi-
cal conditions or by children where its use might be dangerous to health, or against
unsafe dosage or methods or duration of administration in such manner and form
as are necessary for the protection of users since its labeling did not bear warnings
that the tablets contained acetanilid frequent or continued use of which might
be dangerous, causing serious blood disturbances, anemia, collapse, or dependence
on said drug, and that it should not be given to children.
The Compressed Tablets Thyroid Substance were alleged to be misbranded in
that the labeling did not bear adequate directions for use since it bore no di-
rections at all; and in that the labeling failed to bear adequate warnings against
use in those pathological conditions or by children where such use might be
dangerous to health, or against unsafe dosage or methods or duration of admin-
istration in such manner and form as are necessary for the protection of users,
since the article contained thyroid and the labeling failed to bear a warning that
it might cause adverse effects on the body metabolism and the cardiovascular
and central nervous systems, and that it should not be used by persons afflicted by
heart disease or hyperthyroidism.
The Sterile Solution Neohormestrin 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 the labels of all 3 shipments represented that
it possessed in each cubic centimeter a potency equivalent to that possessed by
2,500 International Units of oestrus-producing hormone and the label of one of
the shipments represented that each cubic centimeter possessed a potency equiva-
lent to that possessed by 500 Allen-Doisy rat units, namely, 500 rat units of oestrus-
producing hormone; whereas it possessed a potency lower than that represented,
tests of the three shipments having shown the following results: No. 1 was inert,
No. 2 had a potency equivalent to that possessed by not more than 75 International
Units of oestrus-producing hormone, and No. 3 had a potency equivalent to that
possessed by not more than 55 International Units of oestrus-producing hormone
equivalent to not more than 11 Allen-Doisy rat units. It was alleged to be mis-
branded in that the statements on the label, (2 shipments) "1 c. c. contains 2500
International Units Oestrus Producing Hormone," and (3d shipment) "Neohormes-
trin Each c. c. contains 2500 International * * * Units. 500 Rat (Allen-
Doisey) Units," were false and misleading. One shipment was alleged to be
misbranded further in that it was fabricated from two or more ingredients
and its label did not bear the common or usual name of the active ingredient, i. e.,
oestrus-producing hormones.
to be and was represented as a drug the name of which is recognized in the
National Formulary but its strength differed from and its quality and purity
fell below the standard set forth therein since when tested for oxidizable sub-
stances in accordance with the method prescribed in the'formulary, it required
more than 0.1 cc., namely, 1.6 cc. of twentieth-normal potassium permanganate
to maintain a pink color; whereas the formulary provides that triple distilled
water when tested in accordance with the method prescribed therein, shall require
not more than 0.1 cc. of twentieth-normal potassium to maintain a pink color;
and its difference in strength, quality, and purity from such standard was not
plainly stated on the label. It was alleged to be adulterated further in that minute
particles of rubber had been mixed or packed therewith so as to reduce its quality.
The Ampuls of Sterile Solution Quinine and Urea Hydrochloride were alleged
to be adulterated in that they purported to be and were represented as a drug
the name of which is recognized in the National Formulary, but their strength
differed from and their quality fell below the.standard set forth therein since
each ampul yielded an amount of anhydrous quinine equivalent to less than 54.8
percent, namely, not more than 49.6 percent of the labeled amount of quinine and
urea hydrochloride and 2 cc. of the article contained not more than 12.99 grains
(0.838 gram) of quinine and urea hydrochloride; whereas the formulary specifies
that unless another concentration of the solution is stated on the label, ampuls
of quinine and urea hydrochloride shall contain a sterile solution of approximately
50 grams of quinine and urea hydrochloride in a sufficient quantity of ampul water
to make 100 cc. (which is equivalent to 15? grains (1 gram) of quinine and urea
hydrochloride per 2 cc. ampul), and shall yield an amount of anhydrous quinine
(CjoHwOaNa) corresponding to not less than 54.8 percent of the labeled amount of
quinine and urea hydrochloride; and its difference in strength and quality from
such standard was not stated on the label. They were alleged to be misbranded
in that the statement on the carton and ampul labels, "2 c. c. * * * Quinine
and Urea Hydrochloride 15? Grains (1.0 Gram)," was false and misleading.
The Sterile Supportive Formula S. G. M. a. was alleged to be misbranded (1)
in that its label failed to bear adequate directions for use; and (2) in that it
was fabricated from two or more ingredients and its label did not bear the com-
mon or usual name of each active ingredient. "
The quinine sulfate tablets were alleged to be adulterated in that their strength
differed from that which they purported and were represented to possess in that
they were represented to contain 5 grains of quinine sulfate; whereas each tablet
contained not more than 2.09 grains of quinine sulfate. They were alleged to
be misbranded in that the statement "Quinine Sulfate 5 Grs." was false and
misleading.
One shipment of Solution Epinephrin Chloride was alleged to be adulterated
in that it purported to be and was represented as a drug the name of which is
recognized in the United States Pharmacopoeia but its quality fell below the
standard set forth therein since it contained in each 100 cc. of the solution not
more than 0.05 gram of epinephrine; whereas the pharmacopoeia specifies that the
article (which is recognized therein under the name "solution of epinephrine
hydrochloride") shall consist of "a solution of epinephrine in distilled water and
hydrochloric acid, containing in each 100 cc. not less than 0.095 Gm. * * * of
COHISOJN," and its difference in strength and quality from the pharmacopoeial
standard was not plainly stated on the label. The other shipment of Solution
Epinephrin Chloride was alleged to be adulterated in that it purported to be
and was recognized as a drug the name of which is recognized in the National
Formulary but its strength differed from and its quality fell below the standard
set forth therein since it contained in each cubic centimeter not more than 0.06
gram of epinephrine; whereas the National Formulary specifies that "Unless
otherwise stated on the label, Ampuls of Epinephrine Hydrochloride contain
measured quantities of sterile Solution of Epinephrine Hydrochloride (see U. S.
Pharmacopoeia XI, page 207)," and the said pharmacopoeia specifies that "Solu-
tion of epinephrine hydrochloride is a solution of epinephrine in distilled water
and hydrochloric acid, containing in each 100 cc, not less than 0.095 Gm. * * *
of C9H13O3N," and its difference in strength and quality from the standard set
forth in the formulary was not plainly stated on the label.
The Solution of Ovarian Extract 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 in each cubic
centimeter not less than 50 rat units of ovarian extract; whereas it contained
in each cubic centimeter not more than 4 rat units of ovarian extract. It was
alleged to be misbranded in that the statement on the label, "Ovarian Extract
*    *   *   50 Rat Units per cc." was false and misleading.
On April 20, 1942, a plea of nolo contendere having been entered on behalf of
the defendant, the court imposed a fine of $75 on four of the counts, i. e., a total
of $300; and ordered that imposition of sentence on the remaining counts be sus-
pended for 1 year, that the defendant be placed on probation for 1 year, and
that if no further violation occurred no further penalties be imposed.