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FDA RECALLS & COURT ACTIONS: Feb. 5 & 12, 1992

Executive Summary

CLASS II -- BAYER ASPIRIN (a) Bayer Children's Chewable Aspirin Tablets containing 81 mg each, an OTC product marketed in 36 tablet bottles; (b) Maximum Bayer Aspirin Tablets containing 500 mg each, an OTC product in 60 and 100 tablet bottles; (c) Genuine Bayer Aspirin Tablets containing 325 mg each, an OTC product in 24, 100, 300 and 50 tablets with 10 free tablet bottles; (d) Genuine Bayer Aspirin, an OTC product in 100 caplet bottles. Recall number: D-204/207-2. Lot numbers: (a) 1K319(S); (b) 1K636(S); (c) 1K876(S), 1K870(S), 1L878(S, 1K868(S), 1K867(S), 1K869(S), 1K870(S), 1K866(S), 1K869(S); (d) 1L884(S), 1K861(S). Manufacturer: Sterling Drug, New York, New York. Recalled by: Manufacturer, by telephone and by letters beginning Dec. 8, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 434,628 bottles were distributed; firm estimated 11,330 bottles remained on market at time of recall initiation. Reason: Possible presence of metal particles. CLASS II -- ORAL PEDIATRIC LIQUID ACETAMINOPHEN In 4 ounce containers under the following labels: Mason Distributors, Hy Top Products, Parade, Schein, Hudson Medical, Hi- Tech. Recall number: D-203-2. All lots. Manufacturer: Hi Tech Pharmacal Company, Inc., Amityville, New York. Recalled by: Manufacturer, by telephone during the week of Dec. 23, 1991, followed by letter Jan. 15, 1992. Firm-initiated field correction ongoing. Distribution: Florida, Illinois, New York, Texas. 400 cases (24 bottles per case) were distributed. Reason: Markings on dosage cup not totally compatible with label dosage instructions. CLASS II -- OTC ANALGESIC POWDER PRODUCTS (a) BC Powder, aspirin 650 mg, salicylamide 195 mg, and caffeine 32 mg; (b) Arthritis Strength BC Powder, aspirin 742 mg, salicylamide 222 mg, and caffeine 36 mg. Recall number: D-199/200-2. Lot number 10314 EXP 11/96. Manufacturer: Block Drug Company, Inc., Memphis, Tennessee. Recalled by: Block Drug Company, Inc., Jersey City, New Jersey, by letter Dec. 19-20, 1991. Firm-initiated recall ongoing. Distribution: Alabama, Arkansas, Georgia, Illinois, Louisiana, Mississippi, North Carolina, Ohio, South Carolina, Tennessee. (a) 525 dozen boxes of 24; (b) 129 dozen boxes of 24 were distributed. Reason: Possible presence of metal particles. CLASS II -- THE MEDICINE SHOPPE BRAND MEDI-PHEDRINE PLUS TABLETS A nasal decongestant with antihistamine containing 60 mg pseudoephedrine and 4 mg chlorpheniramine maleate, packaged in blister packs, 24 tablets per box. Recall number: D-209-2. Lot numbers: 1A23C EXP 10/93, 1B68C EXP 11/93, 1E06C EXP 11/93, 1E51C EXP 1/94, 1F65C EXP 6/94, 1G09K EXP 7/94, 1H83C EXP 7/94. Manufacturer: The Perrigo Company, Allegan, Michigan. Recalled by: Manufacturer, by letter Jan. 8, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 5,088 cartons were distributed. Reason: Front panel of cartons incorrectly states 30 mg each. The rear panel ingredient statement and blister pack labeling are correct. CLASS III -- BENZTROPINE MESYLATE TABLETS 0.5 mg, packaged in strips of 10 tablets, 10 strips per box, a Rx oral anticholinergic/antihistaminic used in the treatment of Parkinsonism. Recall number: D-202-2. Lot numbers: 1H627, 1I712, 1I733. Manufacturer: Sidmak Laboratories, Inc., East Hanover, New Jersey. Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter Jan. 7, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 4,199 unit dose cartons were distributed; firm estimates 1,400 cartons remain on the market. Reason: Product does not meet USP specifications for content uniformity. CLASS III -- (a) DIGESTOL BRAND SIMETHICONE; (b) DIGESTOL BRAND ELIXIR (a) Packed in 60 tablet bottles with the following labeled ingredients: pepsin, bile salts, dehydrocholic acid, amylolytic enzyme, lipolytic enzyme and simethicone; (b) In 6 fluid ounce bottles with the following ingredients: pepsin, lactic acid, alcohol. Recall number: D-210/211-2. All lots. Manufacturer: Lex, Inc., Miami, Florida. Recalled by: Kramer Labs, Inc., Miami, Florida, by letter Sept. 18, 1991. Firm-initiated recall ongoing. Distribution: Florida. Approximately (a) 2,731 bottles; (b) 572 bottles were distributed: Reason: Product contains pepsin and dehydrocholic acid, ingredients not permitted by Regulation 310.545. CLASS III -- FLOXIN (OFLOXACIN) 400 mg, a Rx broad-spectrum antibacterial agent for oral administration, packaged 10 tablets per blister strip, 10 blister strips per shelf carton. Recall number: D-208-2. Lot number 91M001 EXP 11/92, Bulk lot number FM2899. Manufacturer: McNeil Laboratories, Spring House, Pennsylvania. Recalled by: Ortho Pharmaceutical Corporation, Raritan, New Jersey, by letter Oct. 10, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 468,800 tablets were distributed. Reason: Packaging error -- Some blister strips contained nine 400 mg tablets and one 300 mg tablet. CLASS III -- LACTULOSE SYRUP USP In 15 ml cups, 10 cups per tray, 10 trays per case, a Rx oral laxative for the treatment of constipation. Recall number: D-201-2. Lot number 102023 EXP 4/92. Manufacturer: Inalco SPA, Milano, Italy for Barre-National, Inc., Baltimore, Maryland. Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter Dec. 31, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 287 cases were distributed; firm estimates 15 cases remain on the market. Reason: Particulate matter. PROSECUTION ACTION FILED -- ERYTHROMYCIN AND PRAZEPAM FORMULAS AND MANUFACTURING PROCESSES Against: John Emmanuel Botzolakis, former Senior Scientist for Parke-Davis Company, Morris Plains, New Jersey. Charge: Stolen confidential commercial information regarding the formulas and manufacturing processes for Erythromycin and Prazepam were transported from New Jersey to New York and given to an official of another generic drug firm in exchange for $14,000. Filed: Oct. 24, 1991 -- U.S. District Court for the District of Maryland, Statement of Facts, Criminal number HAR-91-0328. Plea Agreement: Mr. Botzolakis pleaded guilty to conspiring to transport confidential drug formula information in interstate commerce. SEIZURE ACTION FILED -- MISCELLANEOUS HAIR GROWTH PRODUCTS Charge: Products are unapproved new drugs; Misbranded -- The products' labeling lacks adequate directions for their safe and effective use and the articles were manufactured in an establishment not duly registered as required by regulation. Firm: American Beauty Products, Tulsa, Oklahoma. Filed: Jan. 22, 1992 -- U.S. District Court for the Northern District of Oklahoma; Civil number 92-C-50-E, FDC number 66283. Seized: Jan. 23, 1992 -- goods and printed materials valued at approximately DISPOSITION OF PROSECUTION ACTION -- ANABOLIC STEROIDS Defendant: Dr. George T. Zahorian, Ill, Harrisburg, Pennsylvania. Charge: On June 27, 1991, Dr. George T. Zahorian, Ill, was convicted by a jury in Harrisburg, Pennsylvania, of four counts of distributing anabolic steroids to a body builder who was working as an undercover informant in 1989, four counts of distributing large quantities of Schedule III and IV controlled substances to the same informant, four counts of distributing anabolic steroids to four different professional wrestlers between November 1988 and March 1990, and two counts of using his office condominium complex to facilitate the distribution of steroids and controlled substances. In addition, the jury found that Zahorian's office-condominium, valued at approximately $1.7 million, is subject to forfeiture to the United States. Disposition: On Dec. 27, 1991, Dr. Zahorian was sentenced and a fine of $12,700 was imposed. On each of the 12 counts of conviction for distributing anabolic steroids and controlled substances, Zahorian was sentenced to 36 months imprisonment followed by two years of supervised release. The sentencing will run concurrently. U.S. District Court for the Western District of Pennsylvania. EDITORS' NOTE: A table of all drug recalls listed in FDA "Enforcement Reports" during 1991 is included in the January issue of "The Gold Sheet." The recalls are categorized according to the reason cited by FDA. Single copies of the January issue of the "The Gold Sheet" are available from F-D-C Reports to subscribers at $10 and to non-subscribers at $25.

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