3690. Adulteration and misbranding of conjugated estrogens.   U. S. v. 11,288
Tablets   *    *    *.    (F. D. C. No. 32429.    Sample No. 11619-L.)
LIBEL FILED :    January 11, 1952, Northern District of Ohio.
ALLEGED SHIPMENT : On or about April 9, 1951, by the Keith-Victor Pharmacal
Co., from St. Louis, Mo.
PRODUCT : 24 bottles containing a total of 11,288 tablets of conjugated estrogens
at Cleveland, Ohio. Analysis showed that the product contained a total
amount of estrogenic steroids calculated as 0.71 mg. of sodium estrone sulfate
per tablet.
RESULTS OF INVESTIGATION : The tablets were contained in a drum when shipped
in interstate commerce, and after receipt by the consignee, they were repack-
aged into bottles and relabeled.
LABEL, IN PART: (Drum) "Lot No. 7971 30,000 Sugar Coated Estrogen 1.25
Mg. Tablets."
NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the article
differed from that which it was represented to possess.
Misbranding, Section. 502 (a), the following statement on the drum label
was false and misleading as applied to an article whose equivalent in biologi-
cal activity was less than that declared: "Each tablet contains: Naturally-
occurring water-soluble conjugated estrogens equivalent in biological activity
to 1.25 mg. of sodium estrone sulfate   *    *    *."
DISPOSITION :   March 11,1952.   Default decree of condemnation and destruction.