4986. Various drugs. (F. D. C. No. 38907. S. Nos. 37-041/2 M, 37-045 M
37-048 M, 37-056/9 M, 37-061 M, 37-063 M, 37-067/9 M, 37-073/83 M
37-085 M, 37-087/8 M.)
QUANTITY: 2 btls. containing a total of 1,650 Roncovite tablets; 4 btls. contain-
ing a total of 5,000 Zilatone tablets; 3 btls. and 1 drum containing a total of
28,000 Creamalm tablets; 1 btl. containing 800 Pheno-Bepadol tablets; 9 100-
capsule btls. of Fer-Dona capsules; 2 btls. containing a total of 1,000 Kiophyllin
tablets; 2 btls. containing a total of 650 Pavatrine tablets; 2 btls. containing
a total of 4,000 Amodrine tablets; 1 1,100-capsule btl. of Sulphocol capsules;
6 btls. of Hemosule capsules; 2 btls. containing a total of 1,360 Butisol Sodium
capsules (Mol-Iron tablets) ; 1 1,100-capsule btl., of Propadrme capsules,
92 vials of Dibemsylethylenediamine dipenicillin G oral suspension; 2 btls.
containing a total of 200 Bicillin-Sulfas tablets; 1 btl. containing 109 Sulfa-
biotic tablets; 1 btl,. of Pansulfa with penicillin tablets; 1 btl. of Aureomycin
Spersoids; 8 envelopes containing a total of 700 Diamox tablets; 2 btls. of
Erythrocin; 3 btls. of Thorazine; 3 boxes of Aureomycin capsules; 2 btls.
containing a total of 530 Cortril tablets; 5 60-cc. btls. of pediatric Chloromy-
cetin Palmitate; 9 btls. of penicillin Solvets; 34 1-oz. btls. of Paredrine-Sulfa-
thiazole Suspension; 2 btls. containing a total of 1,800 Ventrex Kapseals; and
4,200 AM Plus capsules in btls. and cartons, at Newark, N. J.
SHIPPED: On unknown dates, from Chicago, 111., Indianapolis, Ind., Detroit,
Mich., Cincinnati, Ohio, Philadelphia, Pa., and Brooklyn, Buffalo, and New
York, N. Y.
LIBELED :   1-13-56, Dist. N. J.
CHARGE: 501 (c)-{Pheno-Bepadol tablets) the strength of the article differed
from that which it purported and was represented to possess, namely, vitamin
Bi (thiamine) 3 milligrams; {Fer-Dona capsules) the vitamin Bi content of
the article fell below the labeled potency in vitamin Bi; (Hemosule capsules)
the vitamin Bi and C content of the article fell below the professed potency
in vitamin Bi and C; {Ventrex Kapseals) the vitamin Bi content of the
article fell below the professed potency in vitamin Bi; and {AM Plus capsules)
the dextroamphetamine sulfate, thiamine hydrochloride, and ascorbic acid
content of the article fell below the professed potency in these substances.
502 (a)-{Pheno-Bepadol tablets) the label statement "Each Tablet con-
tains : * * * vitamin B-l (Thiamine) 3 milligrams" was false and misleading
as applied to a product containing less than the declared amount of vitamin Bj
per tablet; {Fer-Dona capsules) the label statement "Six Capsules * * *
Contains: * * * Vitamin B-l 2 mg." was false and misleading as applied to
a product which contained not more than 1.5 milligrams of vitamin Bi per
6 capsules; {Hemosule capsules) the label statement "Bach Capsule Con-
tains: * * * Thiamine HC1 (Vitamin Bi) 1.0 mg. * * * Ascorbic Acid (Vita-
min C) 15.0 mg." was false and misleading as applied to a product which
contained 0.74 milligram of vitamin Bi and 10 milligrams of vitamin C per
capsule; {Mol-Iron tablets) the label statement "Each Tablet Contains: Fer-
rous Sulfate (3 gr.) 195 mg. Molybdenum Oxide (1/20 gr.) 3 mg." was false
and misleading as applied to a product which contained no ferrous sulfate
or molybdenum oxide; {Ventrex Kapseals) the label statement "Each Kapseal
Represents: * * * Vitamin Bi (Thiamine HC1.) 0.5 mg." was false and mis-
leading as applied to a product which contained 0.22 milligram of vitamin Bi,
per Kapseal; and {AM Plus capsules) the label statement "Each Capsule Con-
tains Dextro-Amphetamine Sulfate 5 mg. * * * Thiamine Hydrochloride 2
mg. * * * Ascorbic Acid 37.5 mg." was false and misleading as applied to a
product which contained no dextroamphetamine sulfate, 1.3 milligrams of
thiamine hydrochloride, and not more than 30 milligrams of ascorbic acid per
capsule.
502 (b) {l)^{Roncovite tablets, Creamalin tablets, Kiophyllin tablets,
Pavatrine tablets, Amodrine tablets, Propadrine capsules, Bicillin-Sulfas tab-
lets, Diamox tablets, Erythrocin, Thorazine, and Cortril tablets) the labels
failed to bear the names and places of business of the manufacturers, packers,
or distributors.
502 (d)-{Pavatrine tablets, Amodrine tablets, and Butisol Sodium capsules
[Mol-Iron tablets']) the articles contained a derivative of barbiiuric acid, and
their labels failed to bear the name, and quantity or proportion of such deriva-
tive and in juxtaposition therewith the statement "Warning-May be habit
forming."
502 (e) (2)-{Roncovite tablets, Zilatone tablets, Creamalin tablets, Kio~
phyllin tablets, Pavatrine tablets, Amodrine tablets, and Diamox tablets) the
labels failed to bear the common or usual name of each active ingredient.
502 (f) (1)-(Roncovite tablets, ZUatone tablets, Creamalin tablets,
Kiophyllin tablets, Patiatrine tablets, Sulphocol Capsules, Mol-Iron tablets,
Propadrine capsules, Diamox tablets, and Paredrine-Sulfathiazole Suspension)
the labeling failed to bear adequate directions for use.
502 (f) (2)-(Propadrine capsules) the labeling failed to bear adequate
warnings to prevent misuse.
502?(1)-(dibenzylethyl?>nediamine dipenicillin O oral suspension, penicillin
Solvets, Bicillin-Sulfas tablets, Sulfabiotic tablets, and Pansulfa with penicil-
lin tablets) the articles were represented as drugs composed in part of
penicillin, and they were not from batches with respect to which certificates
issued pursuant to law were effective; (Aureomycin Spersoids and Aureomycin
capsules) the articles were represented as drugs composed in part of chlor-
tetraeycline, and they were not from batches with respect to which certificates
issued pursuant to law were effective; and (pediatric Chloromycetin Palmi-
tate) the article was represented as a drug composed in part of Chloromycetin,
and it was not from a batch with respect to which a certificate issued pursuant
to law was effective.
503?(b) (4) - (Butisol Sodium capsules [Mol-Iron tablets], Bicillin-Sulfas
tablets, Diamox tablets, Erythrocin, Thorazine, Cortril tablets, and Paredrine-
Sulfathiazole Suspension) the articles were drugs subject to 503 (b) (1),
and their labels failed to bear the statement "Caution: Federal law prohibits
dispensing without prescription."
All articles were adulterated and/or misbranded while held for sale.
The libel alleged also that 12 other products were adulterated and mis-
branded under the provisions of the law applicable to foods, as reported in
notices of judgment on foods.
DISPOSITION :   2-14-56.   Default-destruction.
DRUGS FOE VETERINARY USE