1255. Adulteration and misbranding of procaine hydrochloride solution, with
epinephrine. U. S. v. 38 Packages of Procaine Hydrochloride Solution
(and 3 other seizure actions against procaine hydrochloride solution).
Default decrees of condemnation and destruction. (F. D. C. Nos. 12348,
12407, 12509, 12774. Sample Nos. 35967-F, 35968-F, 50975-F, 63447-F,
75324-F, 75349-F.)
Between the approximate dates of May 10 and June 28, 1944, the United States
attorneys for the Northern District of Georgia, the Eastern District of Pennsyl-
vania, and the Northern District of Ohio filed libels against the following
amounts of procaine hydrochloride solution: 52 packages, each containing
25 cartridges, at Atlanta, Ga.; 38 packages, each containing 25 cartridges, at
Philadelphia, Pa.; and 200 cartridges at Youngstown, Ohio; alleging that the
article had been shipped between the approximate dates of March 8 and May 15,
1944, by A. Pfingst and Pfingst & Co., New York, N. Y.; and charging that it was
adulterated and misbranded. The article was labeled in part: "Procaine Hydro-
chloride [or "HC1"] Solution 2? with Epinephrine."
The article was alleged to be adulterated in that its purity and quality fell
below that which it purported to possess since the article was not sterile, but was
contaminated with living micro-organisms.
The article was alleged to be misbranded in that it was dangerous to health
when used in the dosage suggested in the labeling thereof, that is, when the
. contents of the cartridge were injected into the tissues. A portion of the article
was alleged to be further misbranded in that it failed to bear a label containing
an accurate statement of the quantity of the contents of the package. The label
of this portion bore no statement of the quantity of the contents of each cartridge.
Beween May 29 and July 26, 1944, no claimant having appeared, judgments of
condemnation were entered and the product was ordered destroyed.
DRUGS  ACTIONABLE  BECAUSE   OF  FAILURE  TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS