5642. Vitamin Bu injection.    (F.D.C. No. 40316.    S. No. 43-464 M.)
QUANTITY: 3 ctns. containing a total of 1,550   10-cc. vials at St Louis, Mo.
SHIPPED:   5-20-57, from Chicago,  I1L, by Hallmark Laboratories, Inc.
LABEL IN PART: (Shipping ctns.) "Vitamin 6U 1000 meg. per cc (Cyanoco-
balamin, U.S.P.) in water for injection. Sodium chloride 0.9? Benzyl alco-
hol as bacteriostatic agent, 2? average dose: 1 cc for intramuscular and
intravenous use.    * * * Hallmark Laboratories, Inc., Chicago, Illinois."
BESULTS OF INVESTIGATION : Examination -showed that each cubic centimeter
of the article contained 978 micrograms of cyanocobalamin (vitamin Bu),
8.32 milligrams of sodium chloride, and a quantity of unidentified dis-
solved material.
LIBELED : 6-7-57, E. Dist. Mo.; amended libel 6-18-57 and 4-4-58.
CHARGE: 501(b)-when shipped, the quality and purity of the article fell
below the standard for cyanocobalamin injection set forth in the United
States Pharmacopeia since it contained a quantity of dissolved material
which is not permitted by the standard as an ingredient of cyanocobalamin
injection; and 505(a)-the article, because of the presence of unidentified
dissolved material, was a new drug within the meaning of the law, and an
application filed pursuant to the law was not effective.
DISPOSITION: Hallmark Laboratories, claimant, filed an answer denying that
the article was adulterated or a new drug as charged. The Government filed
written interrogatories which claimant answered in part and objected to
in part. Subsequently, the Government filed a motion to compel further
and more complete answers and also a motion for discovery and production
of documents. The claimant took issue with the Government's motions, and
after a hearing on 12-16-58, the court ordered the claimant to answer some
of the interrogatories and sustained claimant's objections to the remainder.
The Government's motion for discovery and production of documents was
sustained. Thereafter, on 3-11-59, claimant having consented, a decree of
condemnation was entered and the article was destroyed.