December 27, 2000 00-52RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Good Fortune brand Poker-Chip Venus Cooked in Half Shell Clams. Recall #F-067-1. CODE Lot Numbers 77273 and 77274. MANUFACTURER Fujian Hualong Aquatic Trade Development Company, Lianjiang, China. RECALLED BY Universal Group, Ltd., Linden, New Jersey, by letter followed by telephone beginning September 13, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 1,238 cases were distributed. REASON Product was associated with an outbreak of gastroenteritis. In addition, the product is misbranded because it is labeled as "cooked" when in fact the product is raw. ________ PRODUCT CTF brand Pickled Ginger, in 16-ounce (l-pound) glass jars. Recall #F-122-1. CODE None. All product on market at time of recall initiation. MANUFACTURER Combined Thai Foods Company, Ltd., Bangkok, Thailand. RECALLED BY BCN Trading Inc., Brooklyn, New York, by letter dated May 10, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, New Jersey, District of Columbia. QUANTITY 82 cases (24 jars per case) were distributed. REASON Pickled ginger contained sodium saccharin, which is not allowed for use in this type of food, and it contained undeclared sodium benzoate.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Victor’s Lobster Ravioli and Seafood Stuffed Shells: a) Lobster Ravioli, in 1-pound packages (approximately 36 pieces); b) Seafood Stuffed Shells, approximately 2-ounces each, and sold 24 shells per unlabeled bag. Recall #F-117/118-1. CODE All product on market at time of recall initiation. MANUFACTURER Victor Ravioli Foods, Inc., Verona, Pennsylvania. RECALLED BY Manufacturer, by telephone and visit on October 13, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY a) 8 cases; b) 2 cases were distributed. REASON Both products were labeled as containing lobster as an ingredient when none was added. Both products also fail to list all their ingredients and sub-ingredients. Additionally, the Seafood Stuffed Shells do not specify a name and place of business of the manufacturer, packer, or distributor.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Tegretol(r) (carbamazepine), 200 mg, in 100 and 1,000 unit bottles, Rx product indicated for use as an anticonvulsant associated with epilepsy. NDC #0083-0027-30 (100) and NDC 0083-0027-40 (1000). Recall #D-059-1. CODE Lot Numbers: 128B1120 EXP 6/02, 156B3063 EXP 10/02, 158B3063 EXP 10/02, 170D4247 EXP 1/03, 121B9991 EXP 4/02, 137B1238 EXP 6/02, 144B1825 EXP 8/02, 150B2289 EXP 1/02, 155B2289 EXP 10/02, and 1T237018 EXP 9/01. MANUFACTURER Novartis Pharmaceutical Corporation, Suffern, New York. RECALLED BY Manufacturer, by letters on September 18, 2000, and November 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 150,223 bottles to 100’s and 22,363 bottles of 1000’s were distributed. REASON Dissolution failure. ________ PRODUCT Phenazopyridine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles, Rx for the symptomatic relief of pain burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa. Recall #D-062-1. CODE Lot #046060. MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated July 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama. QUANTITY 16,987 units were distributed. REASON Dissolution failure.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Premarin(r) Tablets, 2.5 mg (Conjugated Estrogen Tablets, USP), in 100- count bottles, NDC #0046-0865-81. Recall #D-058-1. CODE Lot Numbers: R9K00522 EXP 08/01, R9K00522A EXP 08/01, R9K00608 EXP 09/01, R9K00608A 09/01. MANUFACTURER Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New York; and Wyeth Pharmaceuticals, Company, Guayama, Puerto Rico. RECALLED BY Bergen Brunswig Corporation, Orange, California, by letter dated November 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 5,086 100-tablet bottles were distributed. REASON Dissolution failure by manufacturer (Wyeth Ayerst). ________ PRODUCT Triple Sulfa Vaginal Cream, USP (Sulfathiazole/Sulfacetamide/Sulfabenzamide), in 2.75-ounce tube, Rx under the Alpharma label. NDC #0472-0700-78. Recall #D-060-1. CODE Lot #L908034 EXP 2/01. MANUFACTURER Alpharma USPD, Inc., Lincolnton, North Carolina. RECALLED BY Manufacturer, by letter on or about September 25, 2000, and letter dated November 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY 37,265 units were distributed. REASON Subpotency of sulfacetamide at 12 month stability testing. ________ PRODUCT Suphedrine Cold & Allergy Tablets (Pseudoephedrine HCl 60 mg & Chlorpheniramine Maleate 4 mg), in 24-tablet units, OTC. Recall #D-061-1. CODE Lot #0032996. MANUFACTURER Leiner Health Products, Wilson, North Carolina. RECALLED BY Leiner Health Products, Carson, California, by letter on November 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arkansas. QUANTITY 1,147,392 tablets were distributed. REASON Failure to manufacture as per validated method -- (reduced blend time and excessive ingredient amount). ________ PRODUCT Pseudoephedrine HCL Tablets, 30 mg, in 24, 32, 48, 96, and 384-count bottles, OTC under the following labels: Finast Suphedrine Nasal Decongestant, Super G Suphedrine Nasal Decongestant, Stop & Shop Suphedrine Nasal Decongestant, Family Pharmacy Pseudoephedrine, Medallion Suphedrine Nasal Decongestant, Your 1st Choice for Value Suphedrine Nasal Decongestant, Brooks Suphedrine Nasal Decongestant, DeMoulas Market Basket Suphedrine Nasal Decongestant, Discount Drug Mart Food Fail Suphedrine Nasal Decongestant, DR duane reade Suphedrine Nasal Decongestant, Family Dollar Suphedrine Nasal Decongestant, Fred's Su-Phedrine Nasal Decongestant, GU Suphedrine Nasal Decongestant, Kinney Brand Suphedrine Nasal Decongestant, Snyder Nasal Decongestant Tablets, Medic Drug Su-Phedrine Nasal Decongestant, MS Pharmaceutical Nasal Decongestant, Smart Choice Suphedrine, Nasal Decongestant, and Equate Suphedrine Nasal Decongestant. Recall #D-063-1. CODE Finast, Super G and Stop & Shop label (American Sales) - 24, 32, 48 & 96 count bottles: 9082936 9104852 9106069 0044035 0055561 0066224 0066694 0GC0388 9034361 9034878 9035045 9057607 9068669 9082079 9094142 0010534 0044034 0GC0117 9035056 9046765 9068515 9129219 8120905 9082207 9128291 9094140 9105257 0019897 0043638 0043786 9094137 9104855 0019404 0019406 0021517 0055205 0055987 0066597 0GC0881 0KC2146 9070335 9070756 9094147 9116552 9127841 0019536 0022101 0066872 0GC0883 9069517 9071128 9104861 0010450 9035138 9046343 9046761 9082311 9094146 9106016 9117038 0032485 0044033 0067330 0GC0118 9023527 9068516 9129216 0GC0116 9129218 Family Pharmacy label (Amerisource) - 24 & 96 count bottles: 9104853 9116778 9117720 9129147 0019448 0019468 0019774 0021516 0032432 0032433 0066596 0GC0389 0GC1215 0HC0687 OKC2326 9034880 9046346 9057119 9058224 9068671 9082158 9082310 9082932 9117435 0019535 0021289 0032548 0GC1217 9046705 9068517 9082148 Medallion label (Ames) - 24 count bottle: 9104850 9106223 9116781 9117592 9128975 0033445 0044031 0055549 0HC0112 OKC1892 0KC2301 9045792 9046344 9046760 9057621 9068664 9069862 9082930 9128975 9069930 9093707 1st Choice label (Bindely Western)- 24 & 48 count bottles: 9082078 9068665 9082078 0033493 0044036 9106224 9128666 0019948 0021103 0022090 0054806 0055648 9056974 Brooks label (Brooks) - 24, 48 & 96 count bottles: 9105258 9117027 0010593 0043788 0055646 0066697 0KC1891 9034884 9046574 9068677 9082080 9129226 9104851 9105847 9116779 9117594 9128667 0010447 0021102 0021514 0033102 0044219 0066308 0067046 0GC0314 9034750 9046345 9070758 9082077 9082307 9082931 9105848 9105849 9105851 9106017 9127842 0019544 0021288 0GC1059 9035141 Demoulas label (Demoulas) - 24 & 48 count bottles: 9105310 9117724 9129156 0010595 0043791 0066836 9035139 9129156 9117154 9129154 0010225 0010449 9046574 9069427 9069499 Discount Drug Mart label (Discount Drug Mart) - 24 & 96 count bottles: 9127962 0019403 0HC0688 9034957 9068668 9070759 0019531 0021975 9035057 9068518 Duane Reade label (Duane Reade)- 24 & 96 count bottles: 0022089 0054892 9057335 0022103 0044571 9057123 0022091 Family Dollar label (Family Dollar) - 24 & 384 count bottles: 9129293 9128996 9128998 9129126 9094404 9094063 9094064 9094065 9094066 9094244 9106070 9106331 9117028 9117096 0010208 0010451 0021974 0032372 0032549 0033097 0033100 0043528 0043783 0044572 0054804 0055422 0066311 0067078 0GC0429 9035050 9045870 9046467 9057125 9057667 9058225 9069859 9070752 9082308 Freds label (Fred's) - 24 count bottle: 9104854 9105615 9106330 0032371 0033422 0043639 0055423 0066310 0067047 0HC0689 0KC2147 0KC2332 9046347 9057620 9070760 Goldline label (Goldline) - 24 count bottle: 9104915 0019318 0019319 9011513 9023646 9056973 9070755 GU label (Grand Union) - 24 count bottle: 9104856 9106328 9117029 0019540 0021104 0043787 0066309 9034881 9058282 9069495 9071585 Kinney Brand label (Kinney Drug) - 24 count bottle: 9106341 9127847 0019469 0032328 0043640 0GC0316 0GC0879 9011669 9057124 9069731 Medic Drug label (Medic Drug) - 24 & 96 count bottle: 9106327 0044573 9068672 9105854 MS Pharmaceutical label (Meyers) - 24 count bottle: 9082934 9104857 9106326 0032370 0MC0275 9046348 9068674 9129220 0KC1893 Smart Choice label (Smart Choice) - 24 count bottle: 9104858 9116776 9117030 9127845 9128669 0010598 0019383 0019541 0019893 0021973 0043641 9035040 9035042 9046764 9060130 9068675 9082157 9082933 Snyder's label (Snyder's) - 24 & 96 count bottle: 9104859 9106325 9117155 9129190 0HC0690 0KC1894 9034372 9035136 9046385 9057033 9068673 9070964 9082309 9105855 9117037 0032700 0044032 9034371 9070699 9071129 Equate label (Wal Mart) - 24 & 96 count bottle: 9071649 9094646 9104849 9106056 9106075 9106440 9106441 9116918 9117252 9117373 9128015 0010174 0010175 0010472 0010749 0019416 0032373 0032547 0043861 0043862 0055507 0055911 0066312 0067395 0GC0390 9023557 9034153 9034576 9034768 9045634 9046349 9046709 9057379 9057666 9070747 9081968 9082312 9093639 9129152 9071278 9071648 9082567 9082619 9082819 9083131 9093544 9094383 9105519 9105783 9105840 9106015 9106324 9106442 9116551 9116691 9117039 9117097 9117405 9127844 9127995 9128236 0010132 0010365 0010366 0010536 0010750 0019530 0019763 0021834 0032544 0032545 0032714 0032715 0043863 0043864 0043865 0044570 0044698 0055283 0055284 0055285 0066184 0066185 0067331 0067332 0GC1218 8121131 9023116 9023404 9033917 9034154 9034507 9034508 9034511 9034834 9034987 9035020 9035264 9045385 9046620 9046622 9068519 9069496 9069953 9070234 9070235 9070236 9070243 9071042 9081967 9093640 9128552 9129125 9129151 Medic W/D label (Winn Dixie) - 24 count bottle: 9104862 9117095 9117359 9127848 9129155 0021105 0032550 0055039 0066696 0GC0317 0KC1896 0KC2120 9045655 9045818 9068676. MANUFACTURER Leiner Health Products, Inc., Wilson, North Carolina. RECALLED BY Leiner Health Products, Inc., Carson, California, by letter on November 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arkansas, California, Connecticut, Florida, Indiana, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee. QUANTITY Volume in commerce: American Sales - 392,544 Amerisource - 139,680 Ames - 53,016 Bindely Western - 14,400 + 30,891 Brooks - 80,352 Demoulas - 40,320 Discount Drug Mart - 37,440 Duane Reade - 16,848 Family Dollar - 609,112 Freds 70,992 Goldline - 204,192 Grand Union - 29,088 Kinney Drug - 21,888 Medic Drug - 5,760 Meyers - 17,856 Smart Choice - 122,112 Snyders - 40,464 Wal Mart - 6,120,896 Winn Dixie - 92,016. REASON Failure to validate manufacturing process (sequence of addition of components.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-316-1. CODE Unit #8508574. MANUFACTURER Poudre Valley Health Systems Blood Bank, Fort Collins, Colorado. RECALLED BY Manufacturer, by fax on September 8, 2000. Firm-initiated recall complete. DISTRIBUTION Colorado. QUANTITY 1 unit was distributed. REASON Blood product was collected from an unsuitable donor. ________ PRODUCT Red Blood Cells. Recall #B-365-1. CODE Unit #19239-1332. MANUFACTURER Blood Systems, Inc., Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 11, 1999, and by letter dated October 25, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Plasma, Frozen. Recall #B-366-1. CODE Unit #0718930. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated March 30, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of hepatitis A. ________ PRODUCT Platelets, Pheresis. Recall #B-394-1. CODE Unit K12435 (distributed as two split units). MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa. RECALLED BY Manufacturer, by letter dated April 12, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Illinois. QUANTITY 2 split units were distributed. REASON Blood product was collected from a donor who should have been deferred due to use of the medication Arthrotec.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma; f) Plasma, Frozen; g) Recovered Plasma. Recall #B-395/401-1. CODE Unit Numbers: a) 20FC04463, 20FC10488, 20LY05794, 20LZ04696, 20LY07856, 20LY09224, 20LY13842, 20FC04471, 20FC04980, 20FC07112, 20FC08089, 20FC04468, and 20GY02708; b) 20LY09224 and 20LY13842; c) 20GE01399, 20GE01453A, 20GE01453B, and 20GE01752; d) 20FC08089; e) 20LY13842; f) 20FC10488; g) 20FC04463, 20LY05794, 20LZ04696, 20LY07856, 20LY09224, 20FC04471, 20FC04980, 20FC07112, 20FC08089, 20FC04468, and 20GY02708. MANUFACTURER The American National Red Cross, Boise, Idaho. RECALLED BY Manufacturer, by telephone on December 4, 1998, and August 6, 1999, followed by letters issued on February 18, 1999, and August 6, 1999. Firm-initiated recall complete. DISTRIBUTION Idaho, California, Montana, Switzerland. QUANTITY a) 13 units; b) 2units; c) 4 units; d) 1 unit; e) 1 unit; f) 1 unit; g) 11 units were distributed. REASON Blood products were either: 1) incorrectly tested for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2); or that tested negative for anti-HIV-1/2, but were collected from donors that should have been deferred due to previous incorrect testing for anti-HIV- 1/2.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT FastTake Compact Blood Glucose Monitoring System, used to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use, under the following trade names: One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S. and Canada); PocketScan Compact Blood Glucose Monitoring System (in the United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in Europe); SmartScan Compact Blood Glucose Monitoring System (in Asia, Middle East, Africa, Europe). Recall #Z-129-1. CODE All meters with serial numbers starting with K, L, M and N. MANUFACTURER Inverness Medical, Inc., Waltham, Massachusetts. RECALLED BY LifeScan, Inc., Milpitas, California, by letter on November 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 846,874 meters were distributed. REASON The meter may display a "y" character instead of a number in the test result.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT VITROS Chemistry Slides: (1) Albumin chemistry slides - labeled "ALB Slides", for quantitative measurement of albumin concentrations in serum or plasma (Catalog #819 6057); (2) BUN/Urea Chemistry Slides, labeled "BUN slides", for quantitative measurement of urea nitrogen concentration in serum, plasma and urine (Catalog #174 3418); (3) Glucose Chemistry Slides, labeled "GLU Slides", for quantitative measurement of glucose concentrations in serum, plasma, urine and CSF (Catalog #170 7801); (4) Potassium Chemistry Slides, labeled "K+ Slides", for the quantitative measurement of potassium concentrations in serum, plasma, and urine (Catalog #161 6200). Recall #Z-116/117-1. CODE a) 0914-0169-1087, 0914-0169-1089, 0913-0170-1078; b) 0111-0503-1067; c) 0001-0543-1017, xxx1018, xxx1020, xxx1028, xxx1029, and xxx1327; d) 4102-0394-1038, xxx1104, and xxx1106. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by telephone on January 25, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 3,846 packs were distributed. REASON The moisture content (humidity) inside the cartridge sleeve might be lower than is typical for these products. The Slides are conditioned at a defined temperature and relative humidity before packaging to optimize performance and handling. The effect of this deviation on shelf life and on-board stability are unknown. Stability claims may not be met and performance may not be effective for intended use. ________ PRODUCT Dall-Miles Cable System, Dall-Miles Beaded Cable Sleeve Set, Wire Surgical, used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Product is gamma sterilized. Recall #Z-122-1. CODE Lot Numbers: IGTW01, IGTX01, IGTZ01. MANUFACTURER SAVA Industries, Inc., Riverdale, New Jersey. RECALLED BY Howmedica Osteonics Corp., Rutherford, New Jersey, by letter dated March 3, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, California, Connecticut, Florida, Kentucky, Massachusetts, Minnesota, Montana, New York, Oregon, Tennessee, Texas, Utah, Idaho, Indiana, Maryland, Virginia, Germany, England, Switzerland, Spain, Auckland. QUANTITY 249 units were distributed. REASON The packages labeled 2.0 beaded cable actually contained non-beaded cable. ________ PRODUCT Bayer ADVIA 120 Automated Hematology Systems: Advia 120 Automated Hematology System; a) Technicon H1 Hematology Systems; b) Technicon H2 Hematology Systems; c) Technicon H3 Hematology Systems; d) Technicon H1 Jr Hematology Systems; e) Technicon H1E Hematology Systems. Recall #Z-123/128-1. CODE All serial numbers. MANUFACTURER Bayer Diagnostics Mfg., Swords, Co Dublin, Ireland. RECALLED BY Bayer Corporation, Elkhart, Indiana (distributor), by letter dated May 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,800 units were distributed. REASON A customer was sprayed with the contents of the waste tank, since he did not release the pressure before opening the tank. Because the contents of the tank have the potential of containing virus and bacterial factors, the firm concludes this represent a health risk. END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2000. ####
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