17249. Adulteration and misbranding of Pro-Dyne oral tablets, Pro-Dyne oral 
capsules, Red-Zyne tablets, and Red-Zyne capsules. U. S. v. 89,380 
Tablets, etc.    (F. D. C. No. 29796.    Sample Nos. 69429-K, 69430-K.)
120-tablet bottles, and 5 dozen 240-tablet bottles of Red-Zyne tablets; 60,380 
Pro-Dyne oral capsules; 6% dozen 30-capsule bottles, %}/% dozen 60-capsule 
bottles, and 2 dozen 120-capsule bottles of Red-Zyne capsules at Duquesne, Pa., 
in possession of the Royal Pharmacal Corp.
RESULTS OF INVESTIGATION : The products were shipped in drums under the 
names of Pro-Dyne oral tablets and Pro-Dyne oral capsules, and portions had 
been repackaged after shipment under the names of Red-Zyne tablets and Red- 
Zyne capsules.
LABEL, IN PART: (Drums, when shipped) "Pro-Dyne Oral Tablets A Dietary 
Supplement Containing B12 with other A. P. F. Factors from fermentation 
products B-Complex Vitamins and Minerals * * * Directions: As a die- 
tary supplement Two Tablets 3 times a day * * * Each Pro-Dyne Tablet 
Supplies; * * * .2 mg. Boron (from Sod. Borate)" and "Pro-Dyne Oral 
Capsules A Dietary Supplement Containing Bi with other A. P. F. Factors 
from fermentation products B-Complex Vitamins and Minerals * * * 
Directions: As a dietary supplement One Capsule 3 times a day * * * 
Each Pro-Dyne Capsule Supplies   *   *   *   .4 mg. Boron (from Sod. Borate)."
(Bottles, repackaged from drums) "Red-Zyne Tablets A Dietary Supple- 
ment Containing the New Red Vitamin B12 with other A. P. F. Factors C- 
omplex Vitamins and Essential Minerals * * * Directions: Two Tablets 
3 times a days' * * * Each Red-Zyne Tablet Supplies: * * * .2 mg. 
Boron (from Sod. Borate)" and "Red-Zyne Capsules A Dietary Supplement 
Containing the New Red Vitamin B12 with other A. P. F. Factors B-Complex 
Vitamins and Essential Minerals * * * Directions: As a dietary supple- 
ment One Capsule Three times a day * * * Each Red-Zyne Capsule 
Supplies: * * * .mg. Boron (from Sod. Borate)." 
NATURE OF CHARGE: Adulteration, Section 402 (a)" (2), the articles contained 
an added poisonous and deleterious substance, sodium borate, which was unsafe 
within the meaning of the law since it is a substance not required in the pro- 
duction of the articles and could have been avoided by good manufacturing 
practice.
Misbranding, Section 403 (a), certain statements on the labels of the drums 
and bottles were misleading. These statements represented and suggested 
that the articles were of special dietary value primarily by reason of their 
vitamin Bw content, and that other constituents enumerated on the labels were 
likely to be of some nutritional value, whereas the special dietary value of the 
articles was due primarily to ingredients other than vitamin B12, and the other 
constituents enumerated on the labels were of no nutritional value.
The articles were adulterated and misbranded in the above respects when 
introduced into, while in, and while held for sale after shipment in, interstate 
commerce.
The articles were alleged also to be misbranded under the provisions of the 
law applicable to drugs, as reported in notices of judgment on drugs and devices.