1016. Adulteration and  misbranding of surgical catgut.    U. S. v. Flanders-Day
Co. Plea of guilty. Fine, $100. (F. D. C. No. 8821. Sample Nos. 22551-F,
32801-F, 32806-F.)
On May 10,1943, the United States attorney for the District of Massachusetts
filed an information against the Flanders-Day Co., a corporation, Boston, Mass.,
alleging shipment on or about August 25, September 17, and October 14, 1942,
from the State of Massachusetts into the States of New York and Pennsylvania
of quantities of surgical catgut which was adulterated and misbranded. The
article was labeled in part: (Carton) "Flanders Standard Sutures and Liga-
tures * * * U. S. P. Surgical Catgut Sterile," and (tubes in 2 of the ship-
ments) "U. S. P. Surgical Catgut."
Examination of samples of the article showed that it was contaminated with
viable aerobic and, in 2 of the shipments, anaerobic, spore-bearing bacteria.
The article was alleged to be adulterated in that it purported to be and was
represented as a drug, surgical catgut, the name of which is recognized in the
United States Pharmacopoeia (second supplement, eleventh revision), an official
compendium, but its quality and purity fell below the standard set forth therein
since it was not sterile and did not meet the test for sterility of solids described
in that compendium.
It was alleged to be misbranded in the statements in the labeling, (cartons)
"U. S. P. Surgical Catgut Sterile," and (tubes) "U. S. P. Surgical Catgut," were
false and misleading.
On May 25, 1943, the defendant having entered a plea of guilty, the court
imposed a fine of $100.