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 10or 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 condition 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 hydrochloride 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 B12 (Cyanocobalamin U.S.P.) vials, the Vitamin B12 (Cyanocobalamin U.S.P.) In Water For Injection vials, and the vials of Vitamin B12 Crystalline U.S.P. 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 cyanocobalamin injection; the 30-cc. vials of Water For Injection U.S.P. contained 2 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 Injection; the Liver Injection U.S.P. (Beef) contained more than 50 percent of the amount of cyanocobalamin shown on the label; the vials of Sterile Progesterone U.S.P. contained viable microorganisms and were not sterile; the B-Complex with Vitamin B12 contained approximately 140 percent of the declared amount of riboflavin and was approximately 66 percent deficient in vitamin B12; and the Liver-Folic Acid-B12 was approximately 66 percent deficient in vitamin B12. 12 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 injection, and by hearings pursuant to Section 305 of the Act; and that despite such warnings, the defendants continued to introduce and cause to be introduced 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 injunction 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 defendants from directly or indirectly introducing or causing to be introduced or delivering or causing to be delivered for introduction into interstate commerce, drugs such as those named above or any similar drugs that are adulterated or misbranded as alleged in the complaint or are new drugs which do not have an effective new drug application on file. The temporary injunction further enjoined the defendants from directly or indirectly causing to be introduced or delivered for introduction into interstate commerce, any drug manufactured, processed, relabeled, or repacked by 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 standard 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; (c) A system of properly identifying and storing raw materials as they are received at the plant is instituted; (d) Batches of drugs in preparation are not manipulated in an improper manner resulting in unwarranted shortages or overages in the final yield; (e) Sampling of finished tablets, injectionables, and all other finished products is done in a representative manner to insure the taking of a representative, adequate sample; (f) Capsules are assayed in finished form rather than in earlier stages of manufacture; (g) The practice of shipping finished batches of drugs prior to analysis or without analysis is discontinued; (h) The distribution of new drugs without effective new drug applica tions is discontinued; (i) At least one qualified person in the plant has sufficient information concerning the new drugs shipped from this plant to eliminate confusions and violations; (j) Adequate samples of incoming raw materials are taken and appropriate analyses of these samples made; (k) Preparation of manufacturing records and forms is done with such clarity, care and completeness that each lot or batch of drugs manufactured, processed, relabeled, or repacked is so identified that the complete manufacturing, packing, and labeling history and control examination reports are readily available and so as to eliminate mistakes and confusion; (1) Each batch or lot of drugs manufactured, processed, relabeled or repacked is properly identified at all times and during all stages of said manufacturing, processing, relabeling, or repacking; (m) Operations involving the weighing out of raw materials and the preparation of formulas and application of labeling are checked by another qualified party in addition to the employee originally performing such duties; (n) Returned goods are recorded, handled, stored, and again disposed of in a manner which will eliminate uncertainty, confusion, and the possibility of mistakes; (0) Samples of each lot of raw materials and each batch or lot of drugs manufactured, processed, relabeled, or repacked by them are taken and retained for the time reasonably necessary for the distribution and use of drugs distributed; and (p) Representatives of the Food and Drug Administration of the Department of Health, Education, and Welfare are given free access to all records and controls pertaining to (1) the receipt of all raw materials or lots of drugs for manufacturing, processing, repacking, or relabeling; (2) the manufacturing, processing, repacking, or relabeling of all lots or batches of drugs; and (3) the distribution of all batches or lots of drugs whether interstate or intrastate, including, but not limited to, the records necessary to establish that adequate control systems have been installed embodying all of the herein listed safeguards for interstate commerce considered necessary to good pharmaceutical manufacturing practice. 6176. Conjugated estrogen powder. (F.D.C. No. 43181. S. No. 11-062 P.) SHIPPED: 5-2-58, from Montreal, Canada, by Steroid Laboratories, Ltd. responded to not more than 14.7 mgs. of estrone per gram. LIBELED: 6-6-59, W. Dist. N.Y. CHARGE: 501 (c)-when shipped and while held for sale, the strength of the article differed from that which it purported and was represented to possess; and 502 (a)—the label statement "Each gram contains 17.1 Mg. Estrogens" was false and misleading since the article contained not more than 14.7 mg. of estrone per gram. DISPOSITION: 2-8-60. Consent-claimed by Steroid Laboratories, Ltd., and relabeled. 6177. Conjugated estrogen granules. (F.D.C. No. 44054. S. No. 86-566 P.) QUANTITY: 4 cans containing a total of about 6,176 grams of estrogen (equine) granules at Buffalo, N.Y. SHIPPED: 9-1-59, from Brooklyn, N.Y., by International Hormones, Inc., after having been imported during 1956, from Steroid Laboratories, Ltd., Montreal, Canada. LABEL IN PART: (Can) "International Hormones, Inc. *** Brooklyn 1, N.Y. 1546 Grams Conjugated Estrogens (Equine) Granules 7.074 mg/gram Estrogens after Hydrolysis *** Control #79001." RESULTS OF INVESTIGATION: Analysis showed the total estrogen content corresponded to not more than 4.61 mgs. of estrone per gram. LIBELED: 2-4-60, W. Dist. N.Y. CHARGE: 501(c)—when shipped and while held for sale, the strength of the article differed from that which it purported and was represented to possess; and 502(a)—the label statement "7.074 mg/gram" was false and misleading as applied to an article which contained 4.61 mgs. of estrone per gram. 6178. Conjugated estrogen powder and conjugated estrogen granules. (F.D.C. No. 43915. S. Nos. 65-949/50 P, 65–960 P.) QUANTITY: 2 cans, 500 grams each, and 3 cans, 2 kilograms each, of estrogen powder, and 7 cans of estrogen granules, at Buffalo, N.Y. SHIPPED: Between July 1954 and 8-5-59, from Montreal, Canada, by Steroid Laboratories, Ltd. LABEL IN PART: (Can) "Product of Steroid Laboratories Limited * * Mon treal, Canada, 500 Grams [or "2 Kilograms"] Conjugated Estrogens (Equine) Powder ✶✶✶ Control No. 71302 [or "73730"]" or "1546 Grams Conjugated Estrogens (Equine) Granules. 5.67 mg/gram *** Control No. 87243." RESULTS OF INVESTIGATION: Analysis showed that the total estrogen content corresponded to not more than (2 cans) 12.6 mgs., (3 cans) 11.2 mgs., and (7 cans) 4.7 mgs. of estrone per gram. LIBELED: 11-17-59, W. Dist. N.Y. CHARGE: 501 (c)—when shipped and while held for sale, the strength of the article differed from that which it purported and was represented to possess; and 502(a)—the label statements of the articles (2 cans) “15.45 mgm/gm," (3 cans) "13.29 mgm/gm," and (7 cans) "5.67 mg/gram" were false and misleading. DISPOSITION: 2-8-60. Consent-claimed by Steroid Laboratories, Ltd., Montreal, Canada; one can was destroyed and the remainder were relabeled. 6179. Vernalin (ophthalmic solution). (F.D.C. No. 43970. S. No. 69-722 P.) QUANTITY: 70 8-oz. cartoned btls. at Trenton, N.J. SHIPPED: 10-27-59, from Philadelphia, Pa., by Wall & Ochs, Inc. LABEL IN PART: (Btl. & ctn.) "Vernalin (Improved) Contains: Sodium Carbonate Monohydrated (Active Ingredient) Camphor Water, Rose Water, Fluorescein Sodium (Diagnostic Agent) Chlorbutanol 0.5% as preservative * Wall & Ochs *** Chestnut Street, Phila." ACCOMPANYING LABELING: Circular entitled "Vernalin." RESULTS OF INVESTIGATION: Examination showed that the article was contaminated with viable microorganisms. CHARGE: 501(c)—when shipped, the quality and purity of the article fell below that which it purported to possess; and 502 (a)—the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for all types of conjunctivitis. DISPOSITION: 1-18-60. Default-destruction. 6180. Digitalis tablets. (F.D.C. No. 43926. S. Nos. 85-337/8 P.) QUANTITY: 160,000 tablets in bulk drums and 48 1,000-tablet btls. at Edgewater, N.J. SHIPPED: During May 1959, from New York, N.Y., by Excel Pharmacal Co. LABEL IN PART: (Drum) "Tablets Digitalis Grains 12 gr." and (btl.) "Excel 1,000 Tablets Digitalis 12 Grains *** USP *** Manufactured by Excel Pharmacal Company, New York, N.Y." RESULTS OF INVESTIGATION: Analysis showed that the digitalis potency of the article was less than the declared potency of 11⁄2 grains per tablet. The tablets in the bottles had been repackaged by the dealer from the bulk drums shipped as described above. CHARGE: 501 (b)-when shipped, the strength of the article fell below the standard for digitalis tablets set forth in the United States Pharmacopeia; and 502(a) the label statement "Digitalis 11⁄2 Grains" was false and misleading. DISPOSITION: 1-11-60. Default-destruction. 6181. Canfield liquid lubricating jelly. (F.D.C. No. 44043. S. No. 98-069 P.) QUANTITY: 24 cases, each containing 12 16-oz. jars, at St. Louis, Mo. SHIPPED: 10-12-59 and 11-18-59, from Minneapolis, Minn., by C. R. Canfield & Co. LABEL IN PART: (Case) "No. 1921 Canfield Original Liquid Lubricating Jelly *** Sterile *** Ipse-Sterilis *** C. R. Canfield & Co. 2736-38 Lyndale Avenue, South, Minneapolis 8, Minnesota * **Control Number 4349." RESULTS OF INVESTIGATION: Examination showed the article was contaminated with viable microorganisms. LIBELED: 1-27-60, E. Dist. Mo. CHARGE: 501 (c)-when shipped, the quality and purity of the article fell below that which it purported and was represented to possess; and 502(a)-the label statement "Original Liquid Lubricating Jelly *** Sterile *** IpseSterilis" was false and misleading as applied to an article that was not sterile. DISPOSITION: 3-28-60. Default-destruction. 6182. Prophylactics. (F.D.C. No. 44356. S. No. 85-083 P.) QUANTITY: 9 ctns., 50 gross boxes each, at Baltimore, Md. SHIPPED: During the week of 2-1-60, from Hartville, Ohio, by Allied Latex Sales Co. LABEL IN PART: "Liquid latex, sold for prevention of disease only, made in U.S.A., C-1-60A." RESULTS OF INVESTIGATION: Examination showed that 1.5 percent of the article was defective in that it contained holes. CHARGE: 501(c)—when shipped, the quality of the article fell below that which it purported to possess; and 502(a)—the label statement “sold for prevention of disease only" was false and misleading as applied to an article containing holes. DISPOSITION: 5-10-60. Default-destruction. DRUG FOR VETERINARY USE 6183. Wirthmore Coccidiosis Treatment. (F.D.C. No. 44260. S. No. 91-065 P.) QUANTITY: 20 100-lb. bags at Plainfield, Conn. SHIPPED: 12-8-59, from Bridgewater, Mass., by Eastern Grain Co. LABEL IN PART: (Bag) "Wirthmore Coccidiosis Treatment Ration 411 Active Drug Ingredient Sulfaquinoxaline .05% *** Manufactured for Wirthmore Feeds, Inc., Waltham, Mass." RESULTS OF INVESTIGATION: Examination showed that the article contained approximately 0.027 percent of sulfaquinoxaline. LIBELED: 3-4-60, Dist. Conn. |