5331. Digitoxin powder and digitoxin tablets.    (F. D. C. No. 40121.   S. Nos. 38-
204/5 M.) 
QUANTITY :   1   6-gram btl. and 1   40,000-tablet drum at St. Louis, Mo.
SHIPPED :   12-14-56, from New York, N. Y., by H. Reisman Corp.
LABEL IN PART: (Btl.) "Digitoxin U. S. P. * * * For Manufacturing,
Processing or Repacking"; (drum) "0.2 mg. C. T. Digitoxin."
RESULTS OP INVESTIGATION : The above tablets were prepared by the consignee
from a portion of the bulk digitoxin powder shipped on the above date.
Examination showed that the powder contained not more than 83.5 percent
digitoxin and that the tablets contained not more than 0.156 milligram of
digitoxin per tablet when assayed by the method specified in the United States
Pharmacopeia. The Pharmacopeia requires that the assay results be not less
than 90 percent of the labeled amount of digitoxin.
LTBET.ED :    4 1 57, E. Dist. Mo.
CHARGE : 501 (b)-the article, when shipped and while held for sale, purported
to be a drug, "Digitoxin," the name of which is recognized in the United States
Pharmacopeia, an official compendium, and its strength differed from, and its
quality fell below, the standard set forth in that compendium.
DISPOSITION :   4-30-57.   Default-destruction.