2559. Adulteration and misbranding of dextrose solution and adulteration of
sodium chloride solution.   U. S. v. 330 Flasks, etc.    (F. D. O. No. 25095.
Sample Nos. 18071-K, 18073-K.)
LIBEL FILED:   July 20,1948, Southern District of Indiana.
ALLEGED SHIPMENT : During the period of March 14, 1947, to March 8, 1948,
by the Continental Pharmacal Co., from Cleveland, Ohio.
PRODUCT: 330 flasks of dextrose solution and 36 flasks of sodium chloride solu-
tion at Indianapolis, Ind.
LABEL, IN PART: "Dextrose 5? in Isotonic Solution of Sodium Chloride ;500
cc. * * * sterile and nonpyrogenic" and "Isotonic Solution of Sodium
Chloride    U. S. P. 500 cc."
NATURE OF CHARGE: Adulteration, Section 501 (b), the articles purported to
be and were represented as "Dextrose and Sodium Chloride Injection" and
"Sterile Isotonic Sodium Chloride Solution for Parenteral Use," respectively,
drugs the names of which are recognized in the United States Pharmacopoeia,
an official compendium, and their quality and purity fell below the official
standards since the articles were contaminated with undissolved material;
and the dextrose solution was contaminated with living micro-organisms and
pyrogen.
Misbranding, Section 502 (a), the statement "This product is sterile and
non-pyrogenic" on the label of the dextrose solution was false and misleading.
DISPOSITION :    September 24, 1948.   Default decree of forfeiture and destruction.