6180. Digitalis tablets.   (F.D.C. No. 43926.   S. Nos. 85-337/8 P.)
QUANTITY: 160,000 tablets in bulk drums and 48 1,000-tablet btls. at Edge-
water, N.J.
SHIPPED :   During May 1959, from New York, N.Y., by Excel Pharmacal Co.
LABEL IN PART: (Drum) "Tablets Digitalis Grains lty gr." and (btl.) "Excel
1,000 Tablets Digitalis V/2 Grains * * * USP * * * Manufactured by Excel
Pharmacal Company, New York, N.Y."
RESULTS OF INVESTIGATION : Analysis showed that the digitalis potency of the
article was less than the declared potency of iy2 grains per tablet. The tablets
in the bottles had been repackaged by the dealer from the bulk drums shipped
as described above.
LIBELED:   11-24-59, Dist. N.J.
CHARGE: 501(b)-when shipped, the strength of the article fell below the
standard for digitalis tablets set forth in the United States Pharmacopeia; and
502(a)-the label statement "Digitalis lYs Grains" was false and misleading.
DISPOSITION :   1-11-60.   Default-destruction.