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UNITED STATES v. ARTICLES OF DRUG

Civ. No. 82-1139.

568 F.Supp. 29 (1983)

UNITED STATES of America, Plaintiff, v. ARTICLES OF DRUG, consisting of the following: 15 CARTONS, more or less each carton containing 12/2500 tablet bottles, labeled in part: (bottle) "ZENITH * * * HYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINE TABLETS * * * 2500 Tablets * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 * * * Control No. 2335-58 * * *" and 1/1000 tablet bottles, more or less, labeled in part: (bottle) "Zenith * * * Hydralazine HCL, Hydrochlorothiazide and Reserpine tablets * * * 1000 tablets * * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 Control No. 2338-58 * * *" 160 cartons, more or less, each carton containing 12/1000 tablet bottles labeled in part: (bottle) "Zenith * * * Hydralazine HCL, Hydrochlorothiazide and Reserpine tablets * * * 1000 tablets * * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 * * * Control No. 2335-62R * * *".

United States District Court, D. New Jersey.

March 21, 1983.

Attorney(s) appearing for the Case

John L. Conover, Ribis, McCluskey, Ruane & Graham, Short Hills, N.J., for defendant.

Ronald H. Clark, Asst. U.S. Atty., Newark, N.J., Donald E. Segal, Rockville, Md., Office of General Counsel, Food & Drug Adm., for plaintiff.

SAROKIN, District Judge.

In December, 1981, during an inspection of Zenith Laboratories, Northvale, New Jersey (Zenith or Claimant), Investigator Elaine M. Hall of the United States Food and Drug Administration (FDA) collected samples of two articles of drug which had been manufactured by Zenith; that is, Lots 2335-58 and 2335-62R of Zenith's Hydralazine HCL, Hydrochlorothiazide and Reserpine Tablets. These samples were analyzed and tested by FDA's National Center...

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