3831. Adulteration and misbranding of stilbestrol tablets.    U. S. v. 233,700
Tablets   *   *   *.    (F. D. C. No. 32985.    Sample No. 49041-L.)
LIBEL FILED :    March 27,1952, Eastern District of New York.
ALLEGED SHIPMENT :   On or about January 21, 1952, by Nysco Laboratories, Inc.,
from Newark, N. J.
PRODUCT :   233,700 stilbestrol tablets at Long Island City, N. Y.
LABEL, IN PAKT: (Tin) "Stilbestrol Tablets 1.0 Mg. * * * Warning:
This is an extremely dangerous and toxic drug. Improper use may result in
severe and even fatal injury * * * Empire Chemical Co., Inc. New' Bruns-
wick, New Jersey."
NATURE OF CHARGE: Adulteration, Section 501 (b), the article purported to be
and was represented as "Diethylstilbestrol Tablets," a drug the name of which
is recognized in the United States Pharmacopeia, an official compendium, and
its strength differed from the official standard. (The standard provides that
diethylstilbestrol tablets contain not less than 90 percent and not more than 110
percent of the labeled amount of diethylstilbestrol. Analysis showed that the
article contained from 122 to 125 percent of the labeled amount.)
Misbranding, Section 502 (a), the label statement "Stilbestrol Tablets 1.0
Mg." was false and misleading as applied to the article, which contained from
1.22 to 1.25 mg. of diethylstilbestrol per tablet.
DISPOSITION: October 29, 1952. Default decree of condemnation and
destruction.