6175. Various drugs. (Inj. No. 350.) COMPLAINT FOR INJUNCTION FILED : 1-23-59, N. Dist. 111., against Hallmark Lab- oratories, Inc., a corporation, Custom Chemical Laboratories, a partnership, John Korabik, president of the corporation, Chicago, 111., and Otto K. Benca, treasurer of the corporation and partner in the partnership, Cicero, 111. CHARGE: The complaint alleged that the defendants were engaged in manu- facturing, preparing, packing, labeling, selling, and introducing and delivering for introduction into interstate commerce, various drugs which were adulter- ated and misbranded as follows: 501(b)-a number of such drugs purported to be drugs the names of which are recognized in the United States Pharmacopeia and the strength of the drugs differed from, or their quality or purity fell below, the standards set forth in such compendium; 501(c)-the strength of a number of such drugs differed from, or their quality fell below, that which they purported and were represented to possess; 502(a)-the labeling of a number of such drugs bore false and misleading statements with respect to the nature and quantity of the ingredients con- tained in the drugs; 502(e) (2)-a number of such drugs were not designated solely by a name recognized in an official compendium, were fabricated from two or more in- gredients, and their labels failed to bear the common or usual name of each active ingredient; and 502(g)-a number of such drugs purported to be drugs the names of which are recognized in the United States Pharmacopeia and they were not labeled as prescribed by such compendium. It was alleged also that the defendants were causing to be introduced and delivered for introduction into interstate commerce, contrary to the provisions of Section 505(a), new drugs which did not have effective new drug appli- cations on file. It was alleged further that, in the manufacturing, packaging, selling and distribution of the drugs, essentially the following methods were used: (a) Hallmark Laboratories, Inc., purchased raw materials from various sources and furnished them to Custom Chemical Laboratories; (b> Custom Chemical Laboratories manufactured bulk solutions of drugs for parenteral injection from said raw materials without making assays either of said raw materials or the prepared bulk solutions made from said raw materials ; and (c) the defendants then caused the bulk solutions to be transported to another manufacturer who repackaged the bulk solutions into either 10- or 30-cc. vials; that said 10- or 30-cc. vials were then returned to the premises of Hallmark Laboratories, Inc., where they were labeled and stored and from where they were distributed in interstate commerce. The complaint alleged further that the adulterated and misbranded con- dition of said drugs resulted from deficiencies in the ingredients of the drugs; the presence in the drugs of ingredients in amounts in excess of those declared on the labels; the presence in the drugs of ingredients other than given on the labels; or the presence in the drugs of foreign matter, due either to inadequate manufacturing facilities, lack of identification control, lack of adequate analyses and formulas, lack of qualified personnel, or lack of other precautions essential to the compounding of potent drugs. For example, the 10-cc. vials of Dexalamine ampuls contained methapyrilene hydro- chloride instead of pyranisamine maleate the ingredient given on the label, and contained racemic amphetamine in the amount of 3.7 milligrams rather than 2 milligrams of dextro-amphetamine sulfate; the Solution of Vitamin Bis (Cyanocobalamin U.S.P.) vials, the Vitamin B& (Cyanocobalamin U.SJ*.) In Water For Injection vials, and the vials of Vitamin B12 Crystalline U.SJP. 1000 Micrograms per cc. in Isotonic Sod. Chloride Soln. with 2? Benzyl Alcohol all contained a substantial amount of unidentified dissolved material not permitted by the United States Pharmacopoeia monograph for cyanoco- balamin injection; the 30-cc. vials of Water For Injection U.8.P. contained ? percent of phenol, an added preservative, and its label failed to reveal that fact and the amount present as required in the United States Pharmacopoeia monograph for Water For Injectian; the Liver Injection U.S.P. (Beef) con- tained more than 50 percent of the amount of cyanocobalamin shown on the label; the vials of Sterile Progesterone U.S.P. contained viable microorgan- isms and were not sterile; the B-Complex with Vitamin B12 contained ap- proximately 140 percent of the declared amount of riboflavin and was approxi- mately 66 percent deficient in vitamin B12; and the Liver-Folic Acid-B12 was approximately 66 percent deficient in vitamin B12. It was alleged further that defendants were well aware that their activities violated the Act; that inspections were made of Hallmark Laboratories, Inc., in 1957 and 1958, and of Custom Chemical Laboratories in 1957, at which times the defendants were informed of the inadequacies encountered; that defendants were further warned by seizures of their vitamin B12 for in- jection, and by hearings pursuant to Section 305 of the Act; and that despite such warnings, the defendants continued to introduce and cause to be intro- duced and deliver and cause to be delivered for introduction into interstate commerce, adulterated and misbranded drugs. DISPOSITION : On 2-6-59, the defendants having consented, a temporary in- junction was entered. The temporary injunction was subsequently extended by consent and on 2-15-60, at which time it was revised, it was extended until 2-15-62. The revised temporary injunction enjoined and restrained the de- fendants from directly or indirectly introducing or causing to be introduced or delivering or causing to be delivered for introduction into interstate com- merce, drugs such as those named above or any similar drugs that are idulterated or misbranded as alleged in the complaint or are new drugs which lo not have an effective new drug application on file. The temporary injunction further enjoined the defendants from directly >r indirectly causing to be introduced or delivered for introduction into nterstate commerce, any drug manufactured, processed, relabeled, or repacked :>y them unless and until: (a)?Sufficient qualified and experienced personnel, including supervisory personnel are employed in the plant to properly operate it; (b)?A properly qualified pharmaceutical chemist is employed to make sufficient analyses of each batch of finished drug to insure that it conforms to the labeling under which it is to be shipped, and to the requirements of the National Formulary or United States Pharmacopoeia or other stand- ard which may be applicable. Lacking this, a representative sample of each finished batch of drugs is submitted to a reliable established outside laboratory for examination and the results of such examination are received prior to shipment;