March 1, 2000 00-09RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT a) D'ARTAGNAN Brand Vegetable Terrine (Vegan Pate), sizes: 10 oz., 3 lb., and "slices" (net wt. 2 oz.), product contains spinach, mushrooms, and roasted red peppers; b) D'ARTAGNAN Brand Truffle Butter, 3.5 oz. and 8 oz. packages, product contains butter, truffles, truffle oil, truffle juice, and soy sauce. Recall #F-116/117-0. CODE Vegetable Terrine Coded by Expiration Date: DEC 03 99 FEB 10 00 DEC 15 99 FEB 18 00 DEC 24 99 FEB 23 00 DEC 29 99 FEB 25 00 DEC 31 99 FEB 28 00 JAN 06 00 MAR 01 00 JAN 07 00 MAR 02 00 JAN 14 00 MAR 03 00 JAN 24 00 MAR 10 00 FEB 03 00 MAR 15 00 FEB 04 00 MAR 20 00 FEB 09 00 Truffle Butter Codes (by date of production, first & last digits=year, 4 middle digits=month & day) 911189 911229 912089 912099 912239 MANUFACTURER Hannelore Gourmet Foods, Huntington, New York. RECALLED BY D'Artagnan, Inc., Ltd., Newark, New Jersey, by telephone, and by letter faxed on or about December 27, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Amount Shipped: 1314 cases of Truffle Butter, 3.5 oz. packages 351 cases of Truffle Butter, 8 oz. packages 4449 cases of Vegetable Terrine, 10 oz. packages 1480 cases of Vegetable Terrine, 3 lb. packages 17 cases of Vegetable Terrine, slices (net wt. 2 oz.) REASON Products may be contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Anderson's Chocolate Covered Cherries, Milk Chocolate, in 1 and 2-pound containers. Recall #F-066-0. CODE All misbranded product distributed since January 1999. MANUFACTURER Anderson's Candies, Baden, Pennsylvania. RECALLED BY Manufacturer, by relabeling boxes and by placing placards at cash registers beginning on November 16, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Pennsylvania. QUANTITY Firm estimated that 36 units remained on market at time of recall initiation. REASON Product contains undeclared sulfites and FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Anderson's Candies Family Choice Assorted Milk Chocolates, Deluxe Assortment, in 1 and 2-pound boxes. Recall #F-067-0. CODE All misbranded product distributed since January 1999. MANUFACTURER Anderson's Candies, Baden, Pennsylvania. RECALLED BY Manufacturer, by relabeling boxes and by placing placards at cash registers beginning on November 16, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Pennsylvania. QUANTITY Firm estimated that 36 units remained on market at time of recall initiation. REASON Product contains undeclared sulfites and FD&C Red No. 40. ________ PRODUCT Minute Maid Grape Soda, in 20 fluid ounce bottles. Recall #F-118-0. CODE MAR0600FWB. MANUFACTURER Coca-Cola Bottling Company of North Texas, Fort Worth, Texas. RECALLED BY Coca-Cola Enterprises, Inc., Atlanta, Georgia, by visit beginning on January 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 2,820 cases of 24 were distributed. REASON Product contains undeclared brominated vegetable oil, gum acacia, and glycerol ester of wood rosin. ________ PRODUCT Cut Green Beans, in #10 cans, Net Contents 6 pounds 6 ounces. Recall #F-119-0. CODE I92191/3441C I92191/3441D I92134/3441D I92211/3441C I92211/3441D I92192/3441C I92163/3441D I92172/3441C I92181/3441D I92152/3441D I92153/3441D. MANUFACTURER Seneca Foods Corporation, Marion, New York. RECALLED BY Seneca Foods Corporation, Janesville, Wisconsin, by letter on November 24, 1999. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Virginia. QUANTITY Undetermined. REASON Product was contained in swollen and leaking cans which would result in spoiled product but are unlikely to pose a hazard to health.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Procanbid(tm) Extended-Release Tablets (Procainamide HCL), 500 mg, in 60 tablet bottles, Rx for use as an anti-arrhythmic. Recall #D-211-0. CODE Product Code: N0071-0562-20, Lot #40697D EXP 7/00. MANUFACTURER Warner Lambert Company, Morris Plains, New Jersey. RECALLED BY The Parke Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by letter on December 23, 1999. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 21,251 bottles were distributed. REASON Dissolution failure (2 hour time point). ________ PRODUCT Q-V Tussin Elixir (Hydrocodone Bitartrate, Pseudoephedrine HCL and Chlorpheniramine Maleate), in 1-pint bottles, under the Qualitest and Vintage labels. Recall #D-220-0. CODE NDC # Lot # EXP 0603-1609-58 038D8A 04/00 0603-1609-58 035F8A 05/00 0254-9403-58 035F8B 05/00 0603-1609-58 004G8A 06/00 0603-1609-58 005G8A 06/00 0603-1609-58 006G8A 06/00 0603-1609-58 034M8A 11/00. MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, Alabama. RECALLED BY Manufacturer, by letter dated January 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 7,928 of lot 038D8A 2,856 of lot 035F8A 5,052 of lot 035F8B 7,745 of lot 004G8A 7,773 of lot 005G8A 7,861 of lot 006G8A 7,942 of lot 034M8A. REASON Lack of assurance chlorpheniramine maleate will maintain potency throughout labeled shelf life.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma; d) Recovered Plasma. Recall #B-271/274-0. CODE Unit Numbers: a) 29FG59198, 29FR93274, 29FC46434; b) 29FR9327; c) 29FR93274; d) 29FG59198, 29FX46266, 29FC46434. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated May 13, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 3 units were distributed. REASON Blood products were collected from a donor with a history of hepatitis. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced, Irradiated; c) Platelets; d) Cryoprecipitated AHF; e) Cryoprecipitated AHF, Pooled; f) Fresh Frozen Plasma; g) Plasma, Cryoreduced; h) Recovered Plasma. Recall #B-395/402-0. CODE Unit Numbers: a) 21GC39174, 21GC33431, 21GC26695, 21GC17776, 21GL27767, 21GG76874, 21Y35689; b) 21GC57900; c) 21GG76874; d) 21GC39174, 21GC33431, 21GC26695, 21GC17776, 21Y35689; e) 21E11552; f) 21GG76874; g) 21GC17776, 21GL27767; h) 21GC39174, 21GC33431, 21GC26695, 21Y35689. Recall #B-395/402-0. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated September 17, 1999. Firm-initiated recall complete. DISTRIBUTION Oregon, California, Oklahoma, Texas, Nebraska, Washington State, Switzerland. QUANTITY a) 7 units; b) 1 unit; c) 1 unit; d) 5 units; e) 1 unit; f) 1 unit; g) 2 units; h) 4 units were distributed. REASON Blood products tested negative for anti-HCV, but was collected from a donor who previously tested repeatedly reactive for anti- HCV, with an indeterminate RIBA test. ________ PRODUCT Cornea. Recall #B-403-0. CODE IN-99-04-058-L-1. MANUFACTURER Indiana Lions Eye Bank, Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated August 23, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit. REASON Cornea was collected from a donor who had been incarcerated. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-420-0. CODE Unit Numbers: 9945018, 9945025, 9950293. MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated September 14, 1998. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 3 units were distributed. REASON Three units of Platelets, Pheresis, which did not have a white blood cell count determination, were labeled as Leukocyte Reduced.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Platelets; b) Platelets, Pheresis. Recall #B-013/014-0. CODE 13FL82907, 13FL82908, 13FL82909, 13FL82910, 13FL82911, 13FL82912, 13FL82914, 13FL82915, 13FL82916, 13FL82917, 13FL82918, 13FL82919, 13FL82922, 13FL82924, 13FL82925, 13FL82926, 13FL82927, 13FL82928, 13FL82929, 13FL82936, 13FL82939, 13FL82942, 13FL82944, 13FL82945, 13FL82946, 13FL82948, 13FL82950, 13FL82951, 13FL82957, 13FL82958, 13FL82960, 13FL82962, 13FL82963, 13FL82964, 13FL82965, 13FL82966, 13FL82968, 13FL82969, 13FL82970, 13FL82971, 13FL82972, 13FL82973, 13FL82974, 13FL82975, 13FL82976, 13FL82978, 13FL82979, 13FL82981, 13FL82982, 13FL82984, 13FL82987, 13FL82988, 13FL82989, 13FL82990, 13FL82991, 13FL82993, 13FL82994, 13FL82995, 13FL82997, 13FL82998, 13FL82999, 13FL83000, 13FL83002, 13FL83003, 13FL83005, 13FL83006, 13FL83010, 13FL83011, 13FL83013, 13FL83014, 13FL83015, 13FL83020, 13FL83022, 13FL83029, 13FL83030, 13FL83031, 13FL83032, 13FL83033, 13FL83034, 13FL83035, 13FL83036, 13FL83037, 13FL83038, 13FL83039, 13FL83041, 13FL83042, 13FL83044, 13FL83045, 13FL83047, 13FL83048, 13FL83049, 13FL83051, 13FL83052, 13FL83053, 13FL83054, 13FM36861, 13FM36862, 13FM36863, 13FM36867, 13FM36868, 13FM36869, 13FM36870, 13FM36871, 13FM36872, 13FM36873, 13FM36875, 13FM36876, 13FM36877, 13FM36879, 13FM36881, 13FM36882, 13FM36883, 13FM36887, 13FM36888, 13FM36889, 13FM37558, 13FN35431, 13FN35437, 13FN35453, 13FN35455, 13FN35457, 13FN35461, 13FN35463, 13FN35464, 13FN35465, 13FN35466, 13FN35468, 13FN35469, 13FN35471, 13FN35472, 13FS63574, 13FS63575, 13FS63576, 13FS63577, 13FS63579, 13FS63580, 13FS63582, 13FS63584, 13FS63585, 13FS63586, 13FS63587, 13FS63588, 13FS63589, 13FS63590, 13FS63591, 13FS63592, 13FS63593, 13FS63594, 13FS63595, 13FS63596, 13FS63597, 13FS63598, 13FS63600, 13FS63602, 13FS63604, 13FY37855, 13FY37857, 13FY37865, 13FY37866, 13FY37867, 13FY37868, 13FY37869, 13FY37870, 13FY37871, 13FY37874, 13FY37875, 13GR04939, 13GR04943, 13GR04945, 13GR04963, 13GR04967, 13GR04968, 13GR04969, 13GR04970, 13GR04971, 13GR04972, 13GR04974, 13GR04978, 13GR04979, 13GR04983, 13GV00003, 13GV00006, 13GV00007, 13GV00009, 13GV00010, 13GV00011, 13GV00012, 13GV00013, 13GV00014, 13GV00015, 13GV00016, 13GV00017, 13GV00018, 13GV00019, 13GV00021, 13GV00023, 13GV00024, 13GV00025, 13GV00026, 13GV00027, 13GV00028, 13GV00030, 13GV00031, 13GV00032, 13GV00033, 13GV00034, 13GV00035, 13GV00036, 13GV00040, 13GV00041, 13GX11551, 13GX11552, 13GX11553, 13GX11555, 13GX11560, 13GX11564, 13GX11567, 13GX11568, 13GX11571, 13GX11578, 13GX11580, 13GX11600, 13GX11601, 13GZ29733, 13GZ29734, 13GZ29735, 13GZ29736, 13GZ29747, 13GZ29749, 13GZ29750, 13LG54017, 13LG54020, 13LG54023, 13LG54024, 13LG54025, 13LG54027, 13LG54028, 13LG54029, 13LG54030, 13LG54034, 13LG54035, 13LG54036, 13LG54039, 13LG54044, 13LG54047, 13LG54048, 13LG54049, 13V99769, 13V99773, 13V99774, 13V99775, 13V99778, 13V99781, 13V99783, 13V99785, 13V99786, 13V99787, 13V99788, 13V99794, 13V99797, 13V99798, 13V99799, 13W91073. b) 13P72150, 13P72152, 13P72155, 13P72150, 13P72150. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on October 20, 1998, and by letter dated November 20, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY a) 263 units; b) 5 units were distributed. REASON Blood products were stored at unmonitored temperatures. ________ PRODUCT Peanut, Arachis hypogaea, in 5 ml vials. Recall #B-421-0. CODE Lot #G9006814. MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on October 21, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 vial was distributed. REASON Allergenic extract, labeled with a concentration of 1,000 PNU/ml, actually contains 835 PNU/ml.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86-88, 100 test kit; an ion capture assay for the quantitative measurement of percent glycated hemoglobin in human anticoagulated whole blood on the IMx Analyzer. Recall #Z-407-0. CODE List # 1A86-88. Set Lot Numbers: 56566M200, 56568M200, 57411M200, 58079M100, 58157M400, 58332M200, 59545M200, 60274M300, 60275M300, 60276M300, 60277M300, 60278M300. MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated February 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 27,444 sets were distributed. REASON The kits may not quantitate the %GHb or give imprecise results. _______ UPDATE Recall #Z-374-0, Fourex Natural Skin Condoms, which appeared in the February 23, 2000 Enforcement Report was incorrectly assigned a recall number and was published prior to appropriate review and evaluation.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Endontic File. Recall #Z-408-0. CODE Part #259446, Lot Numbers: 100799, 110199, 121899 and 051199. MANUFACTURER Maillefer Instruments SA, Ballaigues, Switzerland. RECALLED BH Den-Tal-EZ, Inc., Lancaster, Pennsylvania, by letter on January 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, Georgia, Texas, Florida, Indiana, New York, Illinois, Minnesota, Washington state, Japan. QUANTITY 94 units were distributed. REASON Mislabeled - The wrong size Endostar Files were packaged in part number 259446. END OF ENFORCEMENT REPORT FOR MARCH 1, 2000.####
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