5757. Dianezene tablets.    (F.D.C. No. 41556.    S. No. 3-548 P.)
QUANTITY: 2 drums containing a total of 21,000 tablets in bulk, and 6 btls.,
each containing 50 tablets which had been repackaged from bulk stock at
Washington, D.C., in possession of the Distribution Center, Inc.
SHIPPED :   6-28-57, from Rensselaer, N.Y., by Delmar Pharmacal Corp.
LABEL IN PAET: (Drum) "Lot No. 2531 * * * Special Anti-Radiation Com-
pound (Dianezene) Bach tablet contains: 6? mg. Vitamin Bi 100 mg. Nico-
tinic Acid 100 mg. Ascorbic Acid 6? gr. Dicalcium Phosphate 200 mg.
Iron Reduced N.F. 3? mg. Pantothenic Acid * * * This is a bulk shipment
* * * Delmar Pharmacal, Inc., Rensselaer, N.T."; (btl.) "Dianezene * * *
Manufactured for the Distribution Center, Inc., Box 242 Silver Spring, Mary-
land * * * Each Tablet Contains: Nicotonic Acid 100 mg. Vitamin Bi
6? mg. Di-Calcium Phosphate 6? gr. Pantothenic Acid 3? mg. Ascorbic
Acid 100 mg.   Iron 333 mg."
RESULTS OF INVESTIGATION :   Examination showed that the article contained
198 milligrams of elemental iron, 4.44 milligrams of vitamin Bi, and 75.5
milligrams of ascorbic acid per tablet.
The article was understood to have been recommended by the consignee for
use  in  preventing   and  treating  harmful  effects  caused  by  exposure  to
radioactivity.
LIBELED :   5-7-58, Dist Columbia.
CHARGE: 501(c)-the strength of the article, when shipped and while held for
sale, differed from that which it purported and was represented to possess
since the article contained less than the declared amounts of vitamin Bi,
ascorbic acid, and iron; and 502(a)-the statement on the bulk drum label
"Special Anti-Radiation Compound" was false and misleading since it repre-
sented and suggested that the article was effective for preventing and treating
harmful effects caused by exposure to radioactivity, whereas the article was
not effective for such purposes, and the statements on the labels of the
article with' respect to its content of vitamin Bi, ascorbic acid, and iron were
false and misleading since the article contained less than the declared amounts
of such ingredients.
DISPOSITION :   10-1-58.   Default-destruction.