3672. Adulteration and misbranding of Estrotron (estrogenic hormone).   U. S.
v. 52 Bottles, etc    (F. D. C. No. 31206.    Sample No. 23573-L.)
LIBEL FILED:    June 21, 1951, Southern District of New York.
ALLEGED SHIPMENT : On or about April 17 and 24, 1951, by the Pitman-Moore
Co., from Indianapolis, Ind.
PRODUCT : 52 10-cc. size bottles of Estrotron at New York, N. Y., together with
leaflets entitled "Estrotron." Examination of the article showed that some
of the bottles contained not more than 1.42 milligrams of estrogenic ketosteroids
per cubic centimeter.
LABEL, IN PAST: (Bottle and carton) "10 cc Size * * * Estrotron, 2 mg.
(20,000 I. U.) per cc. in Peanut Oil A highly purified estrus producing extract
from the urine of pregnant mares."
NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the article
differed from that which it was represented to possess, namely, 2 milligrams
of estrogenic ketosteroids per cubic centimeter.
Misbranding, Section 502 (a), the label statements (bottle and carton)
"Estrotron, 2 mg. (20,000 I. U.) per cc * * * consisting primarily of
estrone with smaller amounts of naturally occurring estrogens * * *
standardized to 20,0001. U. of activity per cc" and (leaflet entitled "Estrotron")
"containing 2 mg. of estrogenic substance per cc. equal in estrogenic activity
to 20,000 I. U. per cc." were false and misleading as applied to an article which
contained less than the declared amount of estrogenic ketosteroids per cubic
centimeter.
DISPOSITION : November 29,1951. The Pitman-Moore Co., claimant, having con-
sented to the entry of a decree, judgment of condemnation was entered and
the court ordered that the article be released under bond for treating or re-
processing so that the article would contain the declared amount of estrogenic
ketosteroids per cubic centimeter, under the supervision of the Federal Security
Agency.