United States v. Articles of Drug

568 F. Supp. 29, 1983 U.S. Dist. LEXIS 18396
CourtDistrict Court, D. New Jersey
DecidedMarch 21, 1983
DocketCiv. No. 82-1139
StatusPublished

This text of 568 F. Supp. 29 (United States v. Articles of Drug) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Articles of Drug, 568 F. Supp. 29, 1983 U.S. Dist. LEXIS 18396 (D.N.J. 1983).

Opinion

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 for Drug Analysis. The samples failed to meet the prescribed standards for content uniformity for one of the articles’ components, reserpine.

On April 13, 1982, Plaintiff filed a complaint for forfeiture, alleging that Lots 2335-58 and 2335-62R are adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. Section 351(b), in that they purport to be a drug, but their strength differs from, and their quality falls below, the standard set forth in the United States Pharmacopeia (USP). The complaint alleges that the drugs fail to meet the standard for. content uniformity set forth in the USP. Pursuant to Warrant for Arrest issued by this court, the United States Marshal for this District seized said articles on August 12, 1982. On August 20 Zenith filed a Claim to the articles. On September 7 Zenith filed an Answer.

Zenith has filed a motion to dismiss the complaint for lack of jurisdiction over the subject matter alleging that the seized articles are not “held for sale” after shipment in interstate commerce as required by 21 U.S.C. Section 334(a). Zenith concedes that the articles of drug involved were placed in the stream of interstate commerce before Zenith was advised of the deficiency in the product. Zenith claims that prior to release of the drugs they were tested, with methods at variance with the method set forth in the USP, and found to be acceptable. Zenith argues that the articles were not being “held for sale” either at the time of seizure or at the time of filing of the complaint, because Zenith voluntarily withheld them from sale. Zenith points to an inter office memorandum dated December 22, 1981, directing that Lot number 2335-62R “shall be held pending FDA and Zenith outside laboratory testing results.”

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Cite This Page — Counsel Stack

Bluebook (online)
568 F. Supp. 29, 1983 U.S. Dist. LEXIS 18396, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-articles-of-drug-njd-1983.