1312. Adulteration and misbranding of ampuls of Na-Iodide, sodium salicylate iodide
with colchicine, sodium phenobarbital, and Najodyl. U. S. v. Solex Laboratories,
Inc.   Plea of guilty.   Fine, $500 on 1 count; sentence suspended on 7 counts.
(F. D. C. No. 11344.   Sample Nos. 19029-F, 23415-F, 44655-F, 44658-F.)
On August 23, 1944, the United States attorney for the Southern District
of New York filed an information against the Solex Laboratories, Inc.,
New York, N. Y., alleging shipment from the State of New York into the
States of New Jersey and Pennsylvania of a quantity of the above-named
products between the approximate dates of October 31, 1942, and May 28, 1943.
The Na-Iodide was alleged to be adulterated in that its strength differed
from that which it was represented to possess, since it was represented on the
carton and ampuls as containing 2 percent of sodium iodide, but it contained
not more than 1.71 percent of sodium iodide. The article was alleged to be
misbranded in that the statement on the labeling, "Sodium Iodide 2?," was
false and misleading.
The sodium salicylate iodide with colchicine was alleged to be adulterated
in that it purported to be and was represented as a drug the name of which,
"Ampuls of Sodium Salicylate and Iodide with Colchicine," is recognized in
the National Formulary, an official compendium, but its strength differed from
the official standard in that the Formulary provides that ampuls of sodium
salicylate and iodide with colchicine shall yield anhydrous sodium salicylate
equal to not less than 93 percent of the labeled amount, whereas the article
yielded anhydrous sodium salicylate equal to not more than 88.3 percent of
the labeled amount, and its difference in strength from the standard was not'
plainly stated on the label. The article was alleged to be misbranded in that
the statement "Sodium Salicylate * * * (15? grs.)," on the ampuls contain-
ing the article, was false and misleading since the ampuls contained not
more than 13.7 grains of sodium salicylate.
The sodium phenobarbital was alleged to be adulterated in that its strength
differed from that which it was represented to possess, since it was repre-
sented on the carton and ampul labels as  containing,  in each ampul, .12
*See also Nos. 1302, 1303, 1310.
gram, equivalent to 2 grains of sodium phenobarbital, whereas it contained
not more than .10 gram, equivalent to 1.67 grains of sodium phenobarbital.
The article was alleged to be misbranded in that the statement "Sodium
Phenobarbital .12 Gm. (2 grs.)," on the carton containing the ampuls, and
the statement "2 grs. (.12 Gm.)," on the labels affixed to the ampuls, were
false and misleading.
The Najodyl was alleged to be adulterated in that its strength differed
from that which it purported and was represented to possess, since it was
represented on the carton and ampuls as containing 1 percent of sodium
sulfate, but it contained not less than 1.81 percent of sodium sulfate. The
article was alleged to be misbranded in that the statement "Sodium Sulfate
1?," on the labeling, was false and misleading.
On September 7, 1944, the defendant having entered a plea of guilty, the
court imposed a fine of $500 on count 1, and suspended imposition of sentence
on the remaining 7 counts.