564. Adulteration   of  aromatic   spirit  of  ammonia,   sweet   spirit   of   niter,  and
camphorated oil; and misbranding of Dewee's Carminative. U. S. v. Owens
& Minor Drug Co., Inc. Plea of guilty. Fine, $50. (P. D. C. No. 2965.
Sample Nos. 28853-E, 28855-E, 28856-E, 28858-E.)
This case involved 3 drugs which differed from the requirements of the United
States Pharmacopoeia; also a shipment of Dewee's Carminative which contained
opium and which was not labeled with the warning that it might be habit-forming.
On September 19, 1941, the United States attorney for the Eastern District
of Virginia filed an information against Owens & Minor Drug Co., Inc., of
Richmond, Va., alleging shipment within the period from on or about February
14 to on or about July 31, 1940, from the State of Virginia into the State of
North Carolina of quantities of aromatic spirit of ammonia, sweet spirit of niter,
and camphorated oil which were adulterated, and of a quantity of Dewee's
Carminative which was misbranded.
Adulteration of the aromatic spirit of ammonia, sweet spirit of niter, and
camphorated oil was alleged in that they purported to be or were represented as
drugs the names of which are recognized in the United States Pharmacopoeia,
an official compendium, but their strength differed from, or their quality or
purity fell below, the standards set forth in such compendium in the following
respects: The pharmacopoeia prescribes that aromatic spirit of ammonia shall
contain in each 100 cubic centimeters not less than 1.7 grams and not more than 2.1
grains of total ammonia (NH8), and ammonium carbonate corresponding to not
less than 3.5 grams as (NHOzCOs, whereas the said aromatic spirit of ammonia
contained total ammonia in some instances in excess of the maximum so prescribed,
namely, not less than 2,297 grams of total ammonia per 100 cubic centimeters, and
contained total ammonia in some instances less than the minimum prescribed,
namely, not more than 0.6 gram of total ammonia per 100 cubic centimeters, and it
contained less ammonium carbonate than prescribed, namely, ammonium carbonate
varying from 3.348 grams to 0.793 gram per 100 cubie centimeters; the United
States Pharmacopoeia prescribes that sweet spirit of niter shall contain not less
than 3.5 percent of CsHnONO, namely, ethyl nitrite, whereas the said sweet spirit r f
niter contained less ethyl nitrite than the minimum prescribed, namely, not more
than 3.0 percent; and the United States Pharmacopoeia prescribes that cam-
phorated oil shall contain not less than 19 percent of camphor, whereas the.said
camphorated oil contained less camphor than the minimum prescribed, namely,
not more than 17 89 percent; and the respects in which the strength, quality, or
* S. e also Nos. 550, 551.
purity of said drugs differed from the standards set forth in the said compendium
were not plainly stated on the labels.
Dewee's Carminative was alleged to be misbranded in that it was for use by man
and contained the narcotic or hypnotic substance opium and its label did not
bear the name and quantity or proportion of such substance and in juxtaposition
therewith the statement "Warning-May be habit forming." It was alleged to
be misbranded further in that it was not designated solely by a name recognized
in an official compendium, and 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, kind, and proportion of alcohol.
On October 9,1941, a plea of guilty was entered on behalf of the defendant and
the court imposed a fine of $50.