3689. Adulteration and misbranding of belladonna tincture and paregoric   U. S.
v.  Ormont  Drug &  Chemical  Co.,  Inc.   Plea  of guilty.   Fine,  $525.
(F. D. C. No. 31267.    Sample Nos. 74838-K, 91904-K, 91919-K, 92268-K,
22798-L to 22800-L, incl.)
INFORMATION FILED: January 7, 1952, Eastern District of New York, against
Ormont Drug & Chemical Co., Inc., Long Island City, N. Y.
ALLEGED SHIPMENT:    On or about June 21, September 8, October 13 and 19,
November 9 and 16, and December 20, 1950, from the State of New York into
the States of New Jersey and Connecticut.
LABEL, IN PART :    "Ormont.  *    *    *    Belladonna Tincture   U. S. P.    (Tinctura
Belladonnae)" and "Ormont    *    *    *   Paregoric   U.  S. P.   Tinctura Opii
Gamphorata."
NATURE OF CHARGE: Adulteration, Section 501 (b), both products were rep-
resented to be drugs, the names of which are recognized in the United States
Pharmacopeia, an official compendium, and their strength differed from the
standards set forth in such compendium; and their differences in strength
from the official standards were not stated on their labels. The belladonna
tincture yielded more than 33 milligrams of the alkaloids of belladonna leaf
per 100 cc, and the paregoric yielded more than 45 milligrams of anhydrous
morphine per 100 cc.
Misbranding, Section 502 (a) the statements "Belladonna Tincture U. S. P."
and "Paregoric U. S. P." borne on the labels of the respective products
were false and misleading since the statements represented and suggested
that the drugs were of the strength established in the United States Pharma-
copeia, whereas they were not of such strength in that the belladonna tincture
yielded alkaloids of belladonna leaf in excess of the maximum provided by the
Pharmacopeia, and the paregoric yielded anhydrous morphine in excess of
the maximum so provided.
DISPOSITION : February 13, 1952. A plea of guilty having been entered on
behalf of the defendant corporation, the court imposed a fine of $525.