6320. Contact lens wetting solutions.    (Inj. No. 387.)
COMPLAINT FOR INJUNCTION FILED: 8-23-60, N. Dist. 111., against James H.
Conover, t/a Micon Laboratories, Chicago, 111.
LABEL IN PAST : "MI-CON Wetting Solution A sterile cleanser for PLASTIC
CONTACT LENSES, containing the germicide Benzalkonium Chloride. * * *
Active ingredients: Alkyl dimethyl benzyl ammonium chloride 1:25000
MICON LABORATORIES 905 Jackson St. Wauconda, 111."; "I-SEPTIC
A sterile, Isotonic soothing solution for the wetting and cleansing of plastic
Corneal Lenses. * * * Active ingredient: Alkyl dimethyl benzyl ammonium
chloride, chlorophyll 1:50,000. MICON LABORATORIES 905 Jackson St.,
Wauconda, 111."; "STERL-IZE A sterile isotonic supplement to MICON con-
tact lens fluids. * * * Active ingredients: Merthiolate 1:100,000, Dehydro-
acetic acid sodium salt 0.40?. MICON LABORATORIES Wauconda, 111.";
"STERILEN A sterilizing solution for storing contact lenses STERILIZES
... As it soaks . As it wets . As it cleans To promote greater comfort
and longer wearing time. MICON LABORATORIES 905 Jackson St.
Wauconda, 111. * * * ACTIVE INGREDIENTS: Alkyldimethylbenzyl, Am-
monium Chloride 1:10,000 DHA-S-0.4?"; (vial) "5 cc. Sample UCL Wet-
ting Solution Directions * * * Distributed by United Contact Lens Corp.
76 Madison Ave., New York 16, N.Y." and (ctn.) "Pints W S. Micon From
Micon Labs. Wauconda, 111. to United Contact Lenses 76 Madison Ave.,
New York City."
CHARGE: The complaint alleged that the defendant was engaged in the
business of manufacturing, preparing, packaging, labeling, selling, and dis-
tributing articles of drug, namely, "Mi-Con Wetting Solution," "I-Septic,"
"Sterl-Ize," "Sterilen," and "UCL Wetting Solution;' and that he had been
and was causing to be introduced and delivered for introduction into interstate
commerce, such drugs which were adulterated under 501(c) in that their
purity and quality fell below that which they purported and were represented
to possess since they purported and were represented to be suitable for use in
the eyes and for wetting, cleaning, and storing contact lenses, whereas
they were not suitable for such purposes because they were contaminated
with large numbers of viable micro-organisms and other foreign material;
and, further, that such drugs were misbranded under section 502(a) in that
the labeling of the articles contained false and misleading representations
that the articles were sterile.
It was alleged further that the adulterated and misbranded condition of
such drugs resulted from the presence of foreign material and viable micro-
organisms due to inadequate manufacturing facilities, lack of identification
control, lack of adequate analysis and formula, lack of qualified personnel,
and lack of other precautions essential to the processing and sterilizing of
such drugs.
The complaint alleged also that the defendant was well aware that his
activities were violative of the* Act; that an inspection was made on 4-30-59,
at which time the defendant was warned that various articles of drug were
not sterile; that an inspection was made on 1-20-60, at which time defendant
was warned that questionable procedures were being employed with respect
to insuring the sterility of the products; that seizures of Mi-Con Wetting
Solution and the UCL Wetting Solution had been made; and that despite
such warnings, the defendant continued to introduce adulterated and mis-
branded drugs as indicated above.
DISPOSITION : On 8-24-60, the court entered a temporary restraining order,
without notice, restraining the defendant against the acts complained of.
On 9-2-60, the defendant having consented, the court entered a permanent
injunction enjoining the defendant from directly or indirectly introducing
or causing to be introduced and delivering or causing to be delivered for
introduction into interstate commerce, drugs, such as Mi-Con Wetting Solution,
I-Septio, Sterl-Ise, Sterilen, and UCL Wetting Solution, or any similar drugs
which are represented as suitable for use in the eyes and for wetting,
cleaning, and storing contact lenses, that are (a) adulterated in that they
contain viable micro-organisms, or other foreign material; and (b) mis-
branded in that they contain false and misleading representations that they
are sterile.
The defendant was further enjoined from directly or indirectly introducing
or causing to be introduced or delivering or causing to be delivered for
introduction into interstate commerce, any drugs unless and until-
(a)?sufficient qualified and experienced personnel, including supervisory
personnel, is employed in the plant to properly operate it;
(b)?a properly qualified chemist is employed to make sufficient analysis
of batches of the finished drug to insure sterility and conformity to the
labeling under which it is to be shipped, or other standard which may be
applicable. Lacking this, a representative sample of each finished batch
of drug is submitted to a reliable, established, outside laboratory for
examination prior to shipment;
(c)?a sampling of finished products is done in a representative manner
to insure the taking of a representative and adequate sample ;
(d)?the practice of shipping finished batches of drugs prior to analysis
or without analysis is discontinued; and
(e) a representative of the Food and Drug Administration, Department
of Health, Education, and Welfare, inspects the plant and determines
that adequate control systems have been installed as listed herein, and
as considered necessary in the manufacturing of ophthalmic products.