2304. Misbranding of penicillin sodium.    U. S. v. 998 Cartons    *    *    *.     (F. D. C.
No. 23192.   Sample No. 64200-H.)
LIBEL FILED:    June 18, 1947, Southern District of New York.
ALLEGED  SHIPMENT:   On  or   about  March  28,   1947,  by  Barich,   Inc.,  from
Rutherford, N. J.
PRODUCT: 998 cartons, each containing 5 vials, of penicillin sodium at New
York, N. Y.
LABEL, IN PAST: (Cartons) "5 vials 100,000 Units Each Penicillin Sodium
(Crystalline)    *   *   *   Eto Pharmaeal Company, New York 17, New York."
NATURE OF CHARGE: Misbranding, Section 502 (a), the labeling of the article
was misleading, since it failed to reveal the fact that Eto Pharmaeal Company
was not the manufacturer of the article, which fact was material in the light
of the unmodified words "Eto Pharmaeal Company" appearing on the label;
and the label statement "Lot No. B 5 * * * Nov. 1, 49" was misleading,
in that it represented and suggested that the article had been certified under
such identifying mark in accordance with regulations promulgated by the
Federal Security Administrator, whereas such was not the case.
Further misbranding, Section 502 (f) (1), the labeling of the article failed
to bear adequate directions for use; and, Section 502 (1), the article was repre-
sented as a drug composed wholly of penicillin sodium, a derivative of a kind
of penicillin, and it was not from a batch with respect to which a certificate
or release had been issued pursuant to law.
DISPOSITION: December 17, 1947. Ekstrand & Tholand, Inc., claimant, having
admitted the allegations of the libel, judgment of condemnation was entered
and the product was ordered released under bond to be brought into
compliance with the law, under the supervision of the Food and Drug
Administration.