3451. Adulteration and misbranding of epinephrine bitartrate tablets.   U. S. v.
Graham Chemical Co. and Dr. Samuel D. Goldberg.   Pleas of nolo con-
tendere.    Fine   of   $2  against   company  and  $50  against   individual.
(F. D. C. No. 28106.    Sample Nos. 11257-K, 11295-K.)
INFORMATION FILED: May 17, 1951. Eastern District of New York, against the
Graham Chemical Co., a partnership, Jamaica, N. Y., and Dr. Samuel D.
Goldberg, a partner.
ALLEGED VIOLATION: On or about July 24, 1947, the defendants gave to a firm
engaged in the business of shipping drugs in interstate commerce, a guaranty
to the effect that all articles comprising each shipment or other delivery made
by the company to the holder of the guaranty would be neither adulterated
nor misbranded within the meaning of the law.
On or about October 29, 1948, and February 24, 1949, the defendants shipped
under the guaranty to Long Island City, N. Y., two lots of epinephrine Mtartrate
tablets. As originally filed, the information charged that both shipments of
the drug were adulterated and misbranded, but the adulteration charge was
dismissed with respect to the shipment of October 29, 1948, and the misbrand-
ing charge was dismissed with respect to the shipment of February 24,1949.
?See also No. 3450.
NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the product
in the February 1949 shipment differed from that which it purported and was
represented to possess. The label represented that each tablet contained 0.75
mgm. of epinephrine bitartrate, equivalent to 0.4 mgm. (1/166 grain) of
epinephrine bitartrate, and that 1 cc. of a solution containing one tablet of
the article would equal a solution containing 1 part of epinephrine bitartrate
per 2,600 parts of the solution. However, each tablet of the article contained
less epinephrine bitartrate than so represented, and 1 cc. of a solution con-
taining 1 tablet of the article would equal a solution containing less than 1
part of epinephrine bitartrate per 2,600 parts of the solution.
Misbranding, Section 502 (a), the statements on the label of the article in
the October shipment "Each Tablet Contains : 0.4 mgm. (1/166 grain) Epine-
phrine Bitartrate * * * 1 tablet in 1 cc. equals 1: 2600 Solution" were false
and misleading since the product contained less epinephrine bitartrate than
stated and implied. Further misbranding, Section 502 (a), the statement "U.
S. P." on the label of the article was false and misleading since it represented
that the article was a drug the name of which is recognized by the United
States Pharmacopoeia, whereas the article was not a drug the name of which
is recognized by the United States Pharmacopoeia.
DISPOSITION : May 25, 1951. Pleas of nolo contendere having been entered, the
court imposed a fine of $2 against the partnership and $50 against the indi-
vidual.