2302. Misbranding of Thytocin with Pilocarpine.   U. S. v. George A. Breon & Co.,
Inc.   Plea of nolo contendere.   Fine, $300 and costs.    (P. D. C. No. 23262,
Sample Nos. 50403-H, 55226-H, 83028-H.)
INFORMATION" FILED : May 28,1948, Western District of Missouri, against George
A. Breon & Co., Inc., Kansas City, Mo.
ALLEGED SHIPMENT : On or about August 12, September 7, and October 23, 1946,
from the State of Missouri into the States of Louisiana, Georgia, and Tennessee.
NATURE OF CHARGE: Misbranding, Section 502. (a), the label statements "Each
tablet contains: * * * Pilocarpine hydrochloride . . . ?o gr." was
false and misleading, since each tablet of the article contained more than
?o grain of pilocarpine hydrochloride, i. e., in a portion of the article, approxi-
mately 0.429 grain and, in the remainder, 0.406 grain.
Further misbranding, Section 502 (j), the article was dangerous to health
when used in the dosage and with the frequency and duration suggested in
the labeling "Each tablet contains: * * * Pilocarpine hydrochloride . . .
?o gr. * * * Caution: To be dispensed only by or on the prescription
of a physician." The labeling suggested administration of the article in
dosages appropriate for administration of tablets having a potency of ?o grain
of pilocarpine hydrochloride, whereas the article if administered in dosages
appropriate for the administration of tablets having such potency, would be
dangerous to health, since if prescribed by a physician in reliance upon such
statement of potency, the patient would receive approximately 12 or 13 times
the intended dosage of a potent drug.
DISPOSITION: June 23, 1948. A plea of nolo contendere having been entered,
the court imposed a fine of $300 and costs.