5330. Digitoxin powder.    (F. D. C. No. 40111.    S. No. 56-160 M.)
QUANTITY :   2   25-gram btls. at Chicago, 111.
SHIPPED :   1-16-57, from New York, N. Y., by European Chemical Co., Inc.
LABEL IN PART:    (Btl.)    "Digitoxin U. S. P. * * * Assay:   Digitoxin 99.10%
Loss on drying 0.62%."
RESULTS OF INVESTIGATION :   Examination showed that the article contained not
more than 85 percent of digitoxin when assayed by the method specified in the
United States Pharmacopeia.  The Pharmacopeia requires that the assay result
be not less than 90 percent.
LIBELED :   3-28-57, N. Dist. 111.
CHARGE: 501 (b)-The article, when shipped, purported to be a drug, "Digi-
toxin," the name of which is recognized in the United States Pharmacopeia,
and its strength differed from, and its quality fell below, the standard set forth
in that compendium.
DISPOSITION :   4-23-57.   Default-destruction.
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.
5332. Digitoxin tablets.    (F. D. C. No. 40162.    S. No. 38-211M.)
QUANTITY :   34,772 tablets at St. Louis, Mo.
SHIPPED :   7-6-56 and 11-26-56, from New York, N. Y.
LABEL IN PART : "109a Compressed Tablets Digitoxin, 0.2 mg. Each Tablet
Contains:   Digitoxin, U. S. P. * * * 0.2 mg."
RESULTS OP INVESTIGATION : The tablets were prepared from bulk digitoxin
powder which had been shipped to St Louis, Mo., as described above.
Examination showed that the tablets contained not more than 0.115 milli-
gram of digitoxin per tablet, which equaled 57.3 percent of the declared amount
of digitoxin.
LIBELED :   4-11-57, E. Dist. Mo.
CHARGE : 501 (b)-while held for sale, the strength of the tablets differed from,
and their quality fell below, the standard for digitoxin set forth in the United
States Pharmacopeia since the article contained less than 90 percent of the
labeled amount of digitoxin.
DISPOSITION :   5-10-57.   Default-destruction.