4469. Misbranding of anterior pituitary solution, Vitopit, suprarenal cortex
solution, and Multiglands.   U. S. v. 28 Vials, etc    (F. D. C. No. 36809.
Sample Nos. 58647-L to 58650-L, incl.)
LIBEL FILED :   May 26,1054, Eastern District of Michigan.
ALLEGED SHIPMENT: On or about July 17, 1953, and February 3, 10, and 18,
1954, by the Vitamix Corp., from Philadelphia, Pa.
PRODUCT: 28 vials of anterior pituitary solution, 64 vials of Vitopit,A7 vials of
suprarenal cortex solution, and 468 vials of Multiglands at Detroit, Mich. The
size of each vial was 30 cc.
Analyses showed that the suprarenal cortex solution and the Multiglands
contained no significant quantity of protein.
LABEL, IN PABT : (Vial) "30 cc. Multiple Dose Vial Anterior Pituitary Solu-
tion Sterile?Intramuscular Only * * * Each cc. contains the water soluble
extraction of dried glands derived from: Anterior Pituitary, fresh gland 18-
grains"; "30 cc. Multiple Dose Vial Vitopit * * * Intramuscular Only
* * * Each 2 cc. represents the water soluble extraction of dried glands
derived from: Anterior Pituitary fresh gland. . . . 18? grs. Ovarian Whole
Gland fresh gland. ... 40 grs. Procaine HC1. . . . 1?"; "30 cc. Multiple
Dose Vial Suprarenal Cortex Solution Sterile?Intramuscular Only For
Professional Use Only * * * Each cc. contains a water soluble extract of 2.5
gram of fresh Suprarenal Cortex Tissue * * * Indications: Foreign Protein
Therapy"; and "30 cc. Multiple Dose Vial Multiglands (Plurigland Extract)
Intramuscular Only * * * Each 2 cc. represents the water soluble extraction
of dried glands derived from: Suprarenal Cortex, fresh gland. ... 3.0 grs.
Thyroid U. S. P. . . . 2.0 grs. Pituitary Anterior, fresh gland. ... 1.0
grs. Pituitary Posterior, fresh gland. ... 0.1 grs. Ovarian Substance, fresh
gland. . . . 15.0 grs. Thymus, fresh gland. . . . 3.0 grs. Lymphatic, fresh
gland. ... 3.0 grs. * * * Indications: Non-Specific Protein Therapy."
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the
articles failed to bear adequate directions for use.
Further misbranding, Section 502 (a), the statement "Indications: Foreign
Protein Therapy" on the label of the suprarenal cortex solution and the state-
ment "Indications: Non-Specific Protein Therapy" on the label of the Multi-
glands were false and misleading since such statements represented and sug-
gested that the articles were effective for providing foreign protein reaction
therapy, which was contrary to fact.
DISPOSITION :   July 13, 1954.   Default decree of condemnation and destruction.
DRUGS FOR VETERINARY USE