871. Adulteration and misbranding: of colloidum ipecacuanha, colloldum bella
donna, Lloydrastis. U. S. v. Lloyd Bros., Pharmacists, Inc. Plea of gruilty.
Fine, $400. (F. D. C. No. 7671. Sample Nos. 72234-E, 73014-E, 80378-E,
80379-E.)
On September 15, 1942, the United States attorney for the Southern District
of Ohio filed an information against Lloyd Bros., Pharmacists, Inc., Cincinnati,
Ohio, alleging shipment on or about October 24 and December 12, 1941, and
January 31 and February 7, 1942, from the State of Ohio into the States of
Indiana, California, and Missouri, of quantities of the above-named products.
Analysis of a sample of colloidum ipecacuanha, showed that it contained
not less than 1.32 percent of the ether soluble alkaloids of ipecac. The article
was alleged to be adulterated in that its strength differed from that which it
purported and was represented to possess, that is, not more than 1 percent of
the ether soluble alkaloids of ipecac, whereas it contained 1.32 percent of the
either soluble alkaloids of ipecac. The article was alleged to be misbranded
(1) in that the statement, "Standardized to contain one percent ether soluble
alkaloids," appearing on the label was false and misleading as applied to a
drug that contained not less than 1.32 percent of ether-soluble alkaloids of
ipecac; and (2) in that the statement, "Ipecacuanha * * * Not U. S. P.
One-half the drug strength of the official product," appearing on the label, was
misleading, as the drug was more than one-half the strength of fluidextract of
ipecac as defined and described in the United States Pharmacopoeia.
Analysis of a sample of Lloydrastis showed the article to contain not more
than 0.029 percent of hydrastine. The article was alleged to be adulterated
in that its strength differed from that which it purported and was represented
to possess in that it was represented to contain 0.08 percent of hydrastine,
whereas it contained not more than 0.029 percent of hydrastine. The article
was alleged to be misbranded in that the statement on the labeling, "It is
standardized to an hydrastine content of .08 percent," was false and misleading
as applied to an article that contained a smaller amount of hydrastine.
Analysis of samples from two shipments of colloidum belladonna showed that
one contained not less than 0.517 percent of the total alkaloids of belladonna,
and the other contained not less than 0.57 percent of the total alkaloids of bella-
donna. The article was alleged to be adulterated in that its strength differed
from that which it purported and was represented to possess. The article was
represented to be standardized to> contain not more than .45 percent of the total
alkaloids of belladonna root, but in both instances it contained more of the
total alkaloids of belladonna root than the amount declared. It was also alleged
to be misbranded in that the statement on the label, "Standardized to contain
.45 percent total alkaloids," was false and misleading as applied to an article
containing a higher percentage of the total alkaloids. It was further alleged
to be misbranded in that the statement appearing on the label "Colloidum
Belladonna * * * Not U. S. P. Same drug strength as Fluid Extract," was
false and misleading, since the drug yielded not less than 0.57 gram of the
alkaloids of belladonna root per 100 cc. in the sample from one shipment,
and not less than 0.525 gram of the alkaloids of belladonna root per 100 cc. in
the sample from the second shipment, whereas the United States Pharmacopoeia
provides that "Fluidextract of Belladonna Root yields from each 100 cc,
*    *   *   not more than 0.495 Gm. of the alkaloids of belladonna root."
On October 8, 1942, a plea of guilty having been entered, the court imposed
a fine of $50 on each of the 8 counts of lie information, making a total fine of $400.