3629. Adulteration and misbranding of Estrotron (estrogenic hormone). U. S. v. 9 Dozen bottles * * *. (F. D. C. No. 31208. Sample No. 28281-L.) LIBEL FILED : June 21, 1951, Northern District of California. ALLEGED SHIPMENT : On or about July 6 and 31, 1950 by the Pitman-Moore Co., Div. of Allied Laboratories, Inc., from Indianapolis, Ind. PRODUCT : 9 dozen bottles of Estrotron at Sacramento, Calif. Examination showed that the product contained not more than 1.64 milligrams of estrogenic ketosteroids per cubic centimeter. LABEL, IN PAET : (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, consisting primarily of estrone with smaller quantities of naturally occurring estrogens, dissolved in Peanut Oil and stand- ardized to 20,0001. U. of activity per cc." ?See also No. 3621. 996670-52?2 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 following statements in the labeling of the article were false and misleading since the product contained less than the declared amount of estrogenic ketosteroids per cubic centimeter: (Bottle and carton label) "* * * Estrotron 2 mg. (20,0001. U.) per cc. * * * consisting primarily of estrone with smaller quantities of naturally occurring estrogens * * * standardized to 20,000 I. U. of activity per cc. * * *" and (accompanying leaflet entitled "Estrotron") "* * * containing 2 mg. of estrogenic substance per cc. equal in estrogenic activity to 20,000 I. U. per cc." DISPOSITION : October 29, 1951. The shipper having appeared as claimant and admitted that the product was below potency, judgment of condemnation was entered and the court ordered that the product be released under bond to be reprocessed in compliance with the law, under the supervision of the Food and Drug Administration.