1767. Adulteration and misbranding of Folestrin  Suppositories and pituitary
liquid. U. S. v. Armour and Co. (The Armour Laboratories). Plea of
guilty. Fine, $1,000 and costs. (F. D. C. No. 14215. Sample Nos. 39168-F,
54610-F.)
INFORMATION FILED : June 13,1945, Northern District of Illinois, against Armour
and Co., a corporation, trading as the Armour Laboratories, Chicago, 111.
ALLEGED SHIPMENT: November 1 and 26, 1943, from the State of Illinois into
The State of Indiana.
LABEL, IN PABT: "Armour * * * Folestrin," and "Armour * * * pitui-
tary Liquid."
NATUSE OF CHARGE: Folestrin. Adulteration, Section 501 (c), the strength of
the article fell below that which it purported and was represented to possess,
since each suppository was represented to contain 2,000 International Units
of estrone, whereas each suppository contained not more than 500 International
Units of estrone. Misbranding, Section 502 (a), the label statement, "Each
Suppository Contains 2,000 International Estrogenic Units," was false and
misleading since it represented and suggested that each suppository contained
2,000 International Units of estrone, whereas each suppository contained not
more than 500 International Units of estrone.
Pituitary Liquid. Adulteration, Section 501 (d), a preparation of posterior
pituitary having a potency per cubic centimeter of materially less than 20
U. S. P. posterior pituitary units had been substituted for pituitary liquid
having a potency of 20 U. S. P. posterior pituitary units per cubic centimeter,
which the article was represented to be. Misbranding, Section 502 (a), the
label statements, "Pituitary Liquid Double Strength Solution of Posterior
Pituitary Injection U. S. P. XII 20 U. S. P. Units Per cc," and "The Strength of
This Solution is Double That of the Official U. S. P. Preparation 20 U. S. P.
Units Per cc," were false and misleading since the article did not possess a
potency of double that possessed by posterior pituitary injection of the official
standard, but possessed a potency of not more than two-thirds of that claimed;
and each cubic centimeter of the article did not contain 20 U. S. P. posterior
pituitary units but contained not more than 13? posterior pituitary units.
DISPOSITION : September, 24, 1945. A plea of guilty having' been entered on
behalf of the defendant, the court imposed a fine of $1,000 and costs.