3362. Misbranding of Tibione.   U. S. v. 1 Drum    *    *    *.    (F. D. C. No. 30412.
Sample No. 23054-L.)
LIBEL FILED :   February 1, 1951, Southern District of New York; amended libel
'filed March 1,1951.
ALLEGED SHIPMENT: On or about January 16, 1951, by the Berkeley Chemical
Corp., from Berkeley Heights, N. J.
PRODUCT: 1 drum, containing 43 pounds, of Tibione. Examination disclosed
that the product consisted of 4-acetylaminobenzal thiosemicarbazone, other-
wise known as TB-1 or Tibione.
LABEL, IN PART:    "Tibione-Synonym."
NATURE OF CHARGE:    Section 505 (a), the libel charged as a first cause of action
that the article was a new drug within the meaning of the law, and an ap-
plication filed pursuant to the law was not effective with respect to the
article.
The libel charged also as a second and alternative cause of action that the
.article was misbranded under Section 502 (f) (1), in that its labeling failed
to bear adequate directions for use, and under Section 502 (f) (2), in that
its labeling failed to bear such adequate warnings against unsafe dosage or
duration of administration as are necessary for the protection of users.
DISPOSITION :   March 26,1951.   Default decree of condemnation and destruction.
DRUGS  ACTIONABLE BECAUSE  OF FAILURE  TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS*