1102. Adulteration and misbranding of sodium citrate solution. U. S. v. 1,500
Boxes of Sodium Citrate Solution (and 7 other seizure actions against the
same product). Decrees of condemnation and destruction. (F. D. C. Nos.
9182, 9184, 9232, 9265, 9310, 9311, 9385, 9388. Sample Nos. 3633-F, 5762-F,
10076-F, 16611-F, 29380-F, 29472-F, 34613-F, 37501-F, 41782-F.)
Between January 14 and February 23, 1943, the United States attorneys for the
Western District of Texas, the Northern District of Georgia, the Eastern District
of Virginia, the District of Kansas, the Eastern District of Missouri, the District
of Colorado, the Southern District of Georgia, and the Northern District of Ohio
filed libels against the following quantities of sodium citrate solution: 2,750
ampuls at Savannah, Ga.; 1,500 boxes at San Antonio, Tex.; 4,000 boxes at At-
lanta, Ga.; 2,875 cartons at Richmond, Va.; 3,500 cartons at Kansas City, Kans.;
1,100 cartons at St. Louis, Mo.; 600 packages at Denver, Colo.; and 4,000 boxes
at Toledo, Ohio, each box, carton, and package containing 6 ampuls. They alleged
that the article, which had been consigned by the National Drug Co., had been
shipped from Philadelphia, Pa., within the period from on or about November 12
to December 31, 1942; and charged that it was adulterated and misbranded. On
February 27,1943, an amended libel was filed against the lot at Toledo to correct
the code reference of that lot. On March 18, 1943, the libel against the lot at
Savannah was amended to cover the amount of 5,700 ampuls in lieu of 2,750
ampuls; and a portion of the lot at Savannah having been erroneously seized by
the marshal, an order was entered providing for the return to the United States
Army Medical Depot of 10,500 ampuls out of the total seizure of 16,200 ampuls.
The article was alleged to be adulterated in that it purported to be a drug
the name of which is recognized in the United States Pharmacopoeia, an
official compendium, as "Anticoagulant Solution of Sodium Citrate No. 3-
Sterile Anticoagulant Solution of Sodium Citrate for Parenteral Use," but its
quality and purity fell below the standard set forth in the Pharmacopoeia
since it failed to meet the pyrogen test set forth therein.
It was alleged to be misbranded in that it was dangerous to health when
used in the dosage prescribed, recommended, and suggested in the labeling
thereof, "The contents of a 50 cc. ampul containing the 2y2? solution, mixed
with 450 cc. of blood produces a transfusion mixture"; and in that the statement
in" its labeling, "Ampul Sterile Solution Sodium Citrate, 2?? N. F. For use
in transfusions to prevent the clotting of blood," was misleading since the article
contained pyrogens and was not suitable for use in transfusions, and since the
National Formulary does not recognize the name "Ampul Sterile Solution Sodium
Citrate, 2y2?."
Between February 26 and April 26, 1943, no claim having been presented for
the release of the product, judgments of condemnation were entered and it was
ordered destroyed.
DRUGS ACTIONABLE  BECAUSE  OF  FAILURE  TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS