1908. Misbranding of RX 5000.   U. S. v. 44 Packages of RX 5000.   Consent decree
of. condemnation   and   destruction.     (F.   D.   C.   No.   19990.    Sample   No.
LIBEL FILED :    June 11, 1946, District of Colorado.
ALLEGED SHIPMENT: On or about March 28, 1946, by the Hassenstein Co., from
Hollywood, Calif.
PRODUCT : 44 packages of RX 5000 at Denver, Colo. Examination showed that
each package contained, among other things, 2 cartons, each containing 11
tablets; 1 carton containing 6 capsules; and 3 ampuls containing a liquid.
Analysis showed that the tablets consisted essentially of iron sulfate, plant
material, including aloes and ergot, and essential oils such as oil of pennyroyal;
that the capsules consisted essentially of ergot alkaloids, aloin, oil of savin, and
apiol; and that the ampuls contained solution of posterior pituitary.  .
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the article
failed to bear adequate directions for use since it failed to state why the
article was to be used; and, Section 502 (f) (2), the labeling failed to bear
adequate warnings against use of the article in those pathological conditipns
wherein its use may be dangerous to health since the statement appearing in a
circular, "Ampuls should not be used in cases of nephritis, myocarditis, arteri-
osclerosis, and threatened rupture of the uterus," was not a warning that would
adequately inform the user that the contents of the ampul should not be used
in cases of kidney disease, heart disease, high blood pressure, or hardening of
the arteries.
DISPOSITION : June 26,1946. The Hassenstein Co. having consented to the entry
of a decree, judgment of condemnation was entered and the product was
ordered destroyed.