863. Adulteration and misbranding of tincture of iron and elixir of iron, quinine
and strychnine.    U. S. v. L. Perrigo Company.    Plea of nolo contendere.
Fine, $150.    (F. D. C. No. 7699.    Sample Nos. 47545-E, 47547-E. 66255-E.)
On November 13, 1942, the United States attorney for the Western District
of Michigan filed an information against L. Perrigo Co., a corporation, Allegan,
Mich., alleging shipment of quantities of the above-named products on or about
March 6 and May 2,1941, from the State of Michigan into the State of Indiana.
The United States Pharmacopoeia provides that tincture of iron shall contain
an amount of ferric chloride corresponding to not less than 4.5 grams of iron.
Analysis of a sample of Tincture Iron U. S. P. showed that it contained an amount
of ferric chloride corresponding to not more than 3.15 grams of iron per 100 cc.
The article was alleged to be adulterated in that it purported to be and was
represented as a drug the name of which is recognized in the United States
Pharmacopoeia, and its strength differed from and its quality fell below the
standard set forth in that compendium as the drug contained ferric chloride
corresponding to not more than 3.15 grams of iron per 100 cc. It was alleged to
be misbranded in that the statement, "Tincture Iron U. S. P.," appearing on
the label was false and misleading when applied to a drug which did not conform
to the requirements of the United States Pharmacopoeia.    *
A drug compounded in accordance with the formula for elixir of iron, quinine
and strychnine set forth in the National Formulary must contain an amount of
ferric citrochloride equivalent to not less than 5.60 grams of iron per 1,000 cc,
and must contain not less than 8 grams of quinine hydrochloride per 1,000 cc. Ex-
amination of a sample from each of 2 shipments of Elixir Iron, Quinine and
Strychnine, N. F., showed that the article in one shipment contained an amount
of ferric citrochloride equivalent to not more than 2.80 grams of iron per 1,000 cc.,
and not more than 4.90 grams of quinine hydrochloride per 1,000 cc. A sample
from the second shipment contained not less than* 9.5 grams of quinine hydro-
chloride per 1,000 cc. The article was alleged to be adulterated in that it pur-
ported to be and was represented as a product recognized in the National
Formulary and its strength differed from and its quality fell below the standard
set forth in such compendium. It was alleged to be misbranded in that the
statement, "Elixir Iron, Quinine and Strychnine, N. F.," appearing on the label
was false and misleading when applied to an article which did not conform
to the requirements of the National Formulary.
On November 30, 1942, a plea of nolo contendere having been entered, the
court found the defendant guilty and assessed a fine of $25 on each count, or a
total of $150.