671. Misbranding  of Sterile  Solution Formula  No.  3, Rx Formula  No.  8,  and
S. G. M. a. (Oral). V. S. v. 8 Vials of Sterile Solution Formula No. 3, 12
Boxes of Rx Formula No. 8, and 4 Bottles of S. G. M. a. (Oral). Default
decree of condemnation and destruction. (F. D. C. No. 3911. Sample Nos.
50191-E, 50195-E, 50196-E.)
The labeling of the Sterile Solution Formula No. 3 and S. G. M. a (Oral)
failed to bear adequate directions for use and such adequate warnings as are
necessary for the protection of users and failed to bear the common or usual
names of the active ingredients including the amount of strychnine in the former
and of thyroid in the latter. The labeling of all three products failed to comply
with certain other labeling requirements, as indicated hereinafter.
On February 4, 1941, the United States attorney for the Eastern District of
Virginia filed a libel against the above-named products at Richmond, Va., alleging
that they had been shipped in interstate commerce on or about December 31,1940,
by The Samaritan Treatment from Chicago, 111.; and charging that they were
misbranded.
Analysis of a sample of the Sterile Solution Formula No. 3 showed that it
contained a solution of strychnine, emetine, ephedrine, pilocarpine, and sparteine.
It was alleged to be misbranded (1) in that the label failed to bear adequate
directions for use; (2) in that the label failed to bear adequate warnings against
unsafe dosage or methods or duration of administration in such manner and
form as are necessary for the protection of users; and (3) in that the label
failed to bear the common or usual name of each of the active ingredients,
including the amount of strychnine that it contained.
Analysis of a sample of Rx Formula No. 8 showed that the capsules each con-
tained approximately 0.6 gram of a powder composed chiefly of iron and am-
monium citrate. They were alleged to be misbranded in that they did not bear
a label containing the name and place of business of the manufacturer, packer,
cr distributor; in that they did not bear a label containing a statement of the
quantity of contents of the package; in that the label failed to bear the common
or usual name of the drug; and in that the label failed to bear the common or
usual name of each active ingredient contained therein.
Analysis of a sample of the S. G. M. :. (Oral) showed that it consisted of
capsules containing animal materials including 0.16 grain of thyroid per capsule.
It was alleged to be misbranded in that its labeling failed to bear adequate direc-
tions for use; in that its labeling failed to bear adequate warnings against use
in those pathological 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; in that its
package failed to bear a label containing the name and place of business of the
manufacturer, packer, or-.distribgtor; in that its package failed to bear a label
containing a statement of the "quantity of the contents; in that the label failed
to bear the common or usual name of the article; and in that the label failed
to bear the common or usual name of each active ingredient, including the quan-
tity of thyroid that it contained.
On January 7, 1942, no claimant having appeared, judgment of condemnation
was entered and the products were ordered destroyed.