1853. Adulteration and misbranding of Bactratycin Antibiotic Ointment. U. S.
v. 32 Jars of Bactratycin Antibiotic Ointment. Default decree of con-
demnation and destruction.    (F. D. C. No. 17335.    Sample No. 6350-H.)
LIBEL FILED :    September 11,1945, Southern District of New York.
ALLEGED SHIPMENT : On or about July 26, 1945, by the Wallace Laboratories,
Inc., from New Brunswick, N. J.
PRODUCT :   32 jars of Bactratycin Antibiotic Ointment at New York, N. Y.
NATURE OF CHARGE: Section 505, the article was a new drug in that its compo-
sition was such that, as a result of investigations
 to determine its safety for
use, it had become recognized as safe for use under the conditions prescribed,
recommended, and suggested in its labeling, but it had not, otherwise than in
such investigations, been used to a material extent or for a material time under
such condtions; it was not, prior to June 25, 1938, subject to the Food & Drugs
Act of 1906; and no application had been filed pursuant to the law which was
effective with respect to the article.
Adulteration, Section 501 (c), the strength of the article differed from
that which it purported or was represented by the following statements to
possess, since the article contained no significant proportion, if any, .of gram-
icidin and therefore no significant proportion, if any, of tyrothricin: (Labels)
"Bactratycin Antibiotic Ointment containing Tyrothricin Each gram con-
tains 0.30 mg. Tyrothricin (gramicidin and tyrocidin)" ; and (enclosed circular)
"Ointment containing Tyrothricin Bactratycin * * * utilizing the gram-
positive bacteria-killing properties of tyrothricin * * * employing both
fractions of tyrothricin (gramicidin * * *) Activity: Tyrothricin, the,
active ingredient in Bactratycin * * * Potency: Each gram of Bactratycin
contains 0.30 mg. tyrothricin."
Misbranding, Section 502 (a), certain statements in the circular enclosed
in each package of the article were false and misleading since they represented,
suggested, and implied that the article contained a significant proportion of
gramicidin; that it exhibited an appreciable antibiotic activity such as would
characterize a gramicidin-containing ointment; and that the article would be
effective in the treatment of impetigo, pustular dermatitis, infective derma-
titis, various types of ulcers, abscesses, infected wounds, and similar surface
lesions eaused or complicated by streptococci, staphylococci, pneumococci, or
other gram-positive organisms. The article contained no significant propor-
tion, if any, of gramicidin; it exhibited no appreciable antibiotic activity
such as would characterize a gramicidin-containing ointment; and it would
not be effective in the treatment of the conditions stated.
DISPOSITION : September 13, 1945. No claimant having appeared, judgment of
condemnation was entered and the product was ordered destroyed.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS*