April 12, 2000 00-15RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Regal Sandwich Double Cheeseburger, 6.5 ounces. Recall #F-247-0. CODE All codes on market at time of recall initiation. MANUFACTURER Regal Food Service, Inc., Houston, Texas. RECALLED BY Manufacturer, by letters dated February 7, 14, 28, 2000, and undated letter distributed March 3, 2000. See also FDA press release P00-4, March 4, 2000. Firm-initiated recall complete. DISTRIBUTION Louisiana, Arkansas, Mississippi, Alabama, Florida, Texas. QUANTITY Approximately 4,000-10,000 (a 1 to 2-1/2 and half weeks supply in the stores) remained on market at time of recall initiation. REASON Product may be contaminated with Listeria monocytogenes. ________ PRODUCT Cold Smoked Salmon Pieces, 2-3 pounds each, in unlabeled plastic bags. Recall #F-248-0. CODE None. MANUFACTURER Scandinavian Smoke House, Inc., San Francisco, California. RECALLED BY Manufacturer, by telephone and fax on January 20, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 57 pounds were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Stop & Shop brand Vegetarian Vegetable Condensed Soup, in 10.75 ounce cans. Recall #F-276-0. CODE All codes on the market at time of recall initiation. MANUFACTURER Freddy's Products/Les Produits Freddy, St. Hyaconthe, Quebec, Canada. RECALLED BY Manufacturer, by press release and E-mail on March 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Connecticut, New York, Rhode Island. QUANTITY 292 cases (24 cans per case) were distributed. REASON Product contains undeclared eggs.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Greenwood brand Sweet & Tangy Sliced Pickled Beets, in 16-ounce glass jars. Recall #F-232-0. CODE Top Line: 9AH01 00:00 (4 zeros indicate the military time) Bottom Line: M2KP6. MANUFACTURER Seneca Foods Corporation, Leicester, New York. RECALLED BY Agrilink Foods, Inc., Rochester, New York, by letter on or about March 16, 2000, and by press release on March 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Connecticut, Florida, Georgia, Maine, Maryland, New Jersey, North Carolina, Pennsylvania. QUANTITY 3,444 cases (12 jars per case) were distributed. REASON Product may contain pieces of glass. ________ PRODUCT Barbaris Drink packaged in 1.5-liter rigid plastic bottles. Product of Ukraine. F-234-0. CODE None. MANUFACTURER Morozna Str., Firm "Anna'G", Lviv, Ukraine. RECALLED BY Star of Western Distributors Inc., Brooklyn, New York, by visit and telephone on April 21, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 30 cases (6 bottles per case) were distributed. REASON Product contains the uncertified color additive sunset yellow FCF(certifiable as FD&C Yellow No. 6) and it contains the unapproved color additive carmoisine. ________ PRODUCT Asian Boy (EBQ) Bai Toey Flakes Com Dep, packaged in 7-ounce flexible clear plastic bag. Product of Vietnam. Recall #F-235-0. CODE None. MANUFACTURER M&N Co. 0.8, Ho Chi Minh City, Vietnam. RECALLED BY BCN Trading Inc., Brooklyn, New York, by letter on March 11, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Florida, Pennsylvania, New York, New Jersey, Massachusetts, Connecticut, Georgia, Maryland, District of Columbia. QUANTITY 25 cases (50 bags per case) were distributed. REASON Product contained the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5) and it contained an unapproved blue color. ________ PRODUCT LaPlacita, Inc., brand Chile Molido (Spanish for ground Chile, a spice), in 2-ounce plastic bags. Recall #F-237-0. CODE None. MANUFACTURER La Placita Mexican Products, Brooklyn, New York (Repacker, repacked from bulk product obtained from Mexico). RECALLED BY Repacker, by visit on June 1, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 40 packages were distributed. REASON Product contained the unapproved color additive Ponceau 4R and it contains the color sunset yellow FCF (certifiable as FD&C Yellow No. 6). ________ PRODUCT Haw Cookie, packaged in 5.6-ounce flexible plastic bags. Recall #F-238-0. CODE None. MANUFACTURER Market Group Corporation, Guang Dong, China. RECALLED BY YBL World Wide Trading, Inc., Brooklyn, New York, by telephone on March 12, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 28 cases (100 bags per case) were distributed. REASON Product contained the unapproved color additive Ponceau 4R. ________ PRODUCT Candy Products: a) Shneider's Mehadrin Mallows Cubics b) Shneider's Mehadrin Mallows Pincky's c) Pinduletas Licorice Dragees. Recall #F-240/242-0. CODE a) L0889217-02-99; b) 088912-99; c) Uncoded. MANUFACTURER Shneiders Sarl Tour Essor, Pantin Cedex, France. RECALLED BY Paskesz Candy, Inc., Brooklyn, New York, by telephone and visit on March 22, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION a&b) New York, New Jersey, Michigan, Connecticut; c) Undetermined. QUANTITY a) 111 cases (44 pounds per case); b) 60 cases (44 pounds per case); c) 5 cases (30.8 pounds per case) were distributed. REASON a) Product contained unapproved colors, Ponceau 4R (E124, Acid Red 18) and Quinoline Yellow (E104). The product also contained an unidentified blue color. b) Product contained the unapproved color Ponceau 4R (E124, Acid Red 18). c) Product contained the unapproved colors Ponceau 4R (E124, Acid Red 18) and Quinoline Yellow (E104). The product also contained an unidentified blue color. ________ PRODUCT Jelly Candies: a) National Bakery brand Jelly Slices packaged in plastic lined cardboard box, net wt. 5 lbs. b) National Bakery brand Jelly Swirls packaged in plastic lined cardboard box, net wt. 5 lbs. c) National Bakery brand Jelly Wedges packaged in plastic lined cardboard box, net wt. 5 lbs. d) National Bakery brand Jelly in Chocolate packaged in plastic lined cardboard box, net wt. 5 lbs. Recall #F-243/246-0. CODE None. MANUFACTURER 273 Brighton Beach Avenue Restaurant, Inc., doing business as National Bakery, Brooklyn, New York. RECALLED BY Manufacturer, by letter on April 19, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Undetermined. QUANTITY Approximately 400 boxes of each product were distributed. REASON Products contained undeclared FD&C Yellow No. 5 and FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Trappey's Jalapeno BlackEye Peas Flavored with Slab Bacon, in 15.5-ounce metal cans. Recall #F-233-0. CODE 92923/CMG2 and 92924/CMG2 (but only those portions of these codes that were shipped to WalMarts) MANUFACTURER Allen Canning Company, Alma, Arkansas. RECALLED BY Manufacturer, by letter dated December 14, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi and Arkansas. QUANTITY 183 cases (4,392 cans) were distributed. REASON Some cans actually contained cut mustard greens. ________ PRODUCT Keiloong brand Egg Noodle, packaged in 14-ounce plastic bags, Product of China. Recall #F-236-0. CODE None. MANUFACTURER United Noodle Factory, Hong Kong. RECALLED BY Wicsun Trading, Inc., Brooklyn, New York, by letter on March 18, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 165 cases (40 bags per case) were distributed; firm estimates none remains on the market. REASON Product did not meet the standard of identify for noodles as specified in 21 CFR 139.150 because it did not contain the required amount of egg solids. ________ PRODUCT STR brand Quick Cooking Egg Noodles, packaged in 14-ounce plastic bags. Recall #F-239-0. CODE None. MANUFACTURER Undetermined in China. RECALLED BY Strong International Trading Corporation, Long Island City, New York, by letter on January 21, 1999. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets. DISTRIBUTION New York, Illinois, Florida, Pennsylvania, Connecticut, New Jersey, Massachusetts, Rhode Island. QUANTITY Undetermined. REASON Product did not meet the standard of identify for noodles as specified in 21 CFR 139.150 because it did not contain the required amount of egg solids.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Nasacort(r) AQ, Nasal Spray (Triamcinolone acetonide-16.5 grams), 120 metered acutations, Rx for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older. NDC #0075-1506-16. Recall #D-261-0. CODE Lot #MN3270 EXP 12/00. MANUFACTURER Rhone Poulenc Rorer, Puerto Rico, Inc., Manati, Puerto Rico. RECALLED BY Aventis (formerly Rhone Poulenc Rorer), Collegeville, Pennsylvania, by letter dated February 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Thailand. QUANTITY 45,900 units were distributed; firm estimates none remains on the market. REASON Super-potency (stability).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Isoxsuprine HCL Tablets, 10 mg and 20 mg, USP, in 100 and 1,000 tablet bottles, Rx indicated for the relief of symptoms associated with cerebral vascular insufficiency. under the following labels: Eon: NDC 0185-0530-01 (10 mg, bottles of 100s) NDC 0185-0530-10 (10 mg, bottles of 1000s) NDC 0185-0531-01 (20 mg, bottles of 100s) NDC 0185-0531-10 (20 mg, bottles of 1000s) Major: NDC 0904-0635-60 (10 mg, bottles of 100s) NDC 0904-0636-60 (20 mg, tablets of 100s) NDC 0904-0636-80 (20 mg, bottles of 1000s). Recall #D-259/260-0. CODE All lots within expiration date. MANUFACTURER Eon Labs Manufacturing, Inc., Laurelton, New York. RECALLED BY Manufacturer, by letters dated November 19, 1999, January 12, 2000, and February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10 mg bottles of 100s, Eon Label: 42,009 units Major Label: 3,180 units 10 mg bottles of 1000s, Eon Label: 901 units Major Label: 0 units 20 mg bottles of 100s, Eon Label: 27,911 units Major Label: 1,707 units 20 mg bottles of 1000s, Eon Label: 6,291 units Major Label: 2,169 units. REASON Dissolution failure (42 month stability). ________ PRODUCT CIS-Sulfur Colloid(tm) Kit (Technetium Tc 99m Sulfur Colloid Injection), used in adults and children as an agent for imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. Recall #D-262-0. CODE Lot No. EXP 6363A 12/31/99 6364 1/31/00 6365A 1/31/00 6366A 2/29/00 6367A 1/31/00 6368 2/29/00 6369 2/29/00 6370A 3/31/00 6371 4/30/00 6372 4/30/00 6373B 4/30/00 6374B 6/30/00 6375B 9/30/00 6376 10/31/00 6377B 12/31/00. MANUFACTURER CIS-US, Inc., Bedford, Massachusetts. RECALLED BY Manufacturer, by letter on February 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, New Zealand, Panama, Puerto Rico, Guam. QUANTITY 11,548 kits. REASON Misbranding - Solution B vial has reversed the strength (mg/ml) of the two ingredients on its immediate vial label. ________ PRODUCT CombiPatch(tm) Transdermal System, (estradiol-0.62 mg/norethindrone acetate-2.7mg), Rx used by women with an intact uterus for treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; and treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. NDC #0075-0514-08. Recall #D-263-0. CODE Lot Numbers: 8F0308E1C1 EXP 4/00 and 9D2703E1C1 EXP 2/01. MANUFACTURER Noven Pharmaceuticals, Inc., Miami, Florida. RECALLED BY Aventis (formerly Rhone Poulenc Rorer), Collegeville, Pennsylvania, by letter on February 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Bermuda, Puerto Rico. QUANTITY 41,810 boxes of lot 8F0308E1 and 23,350 boxes of lot 9D2703E1C1 were distributed. REASON Dissolution and appearance specification failure (excess crystals).RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT LIFEPAK 500 Automated External Defibrillator (AED), designed to be used by first responders to cardiac emergencies. Recall #Z-442-0. CODE All serial numbers with more than 8 digits. All serial numbers with 6 digits. 7 digit serial numbers less than 7925937 and serial number 8631084. MANUFACTURER Medtronic Physio-Control Corporation, Redmond, Washington. RECALLED BY Manufacturer, by Tech Memo #3 issued in June 1998, Tech Memo #3a on February 7, 2000, by Technical Service Update on March 23, 2000, and visit with letter dated March 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 8,031 units were distributed. REASON Potential damage/failure of resistor R4 could result in unusable unit next use. ________ PRODUCT Irrigation Administration Sets, used to provide irrigating solution to the surgical field as well as other various uses: a) BSS and BSS Plus Sterile Irrigation Solution Administration Set, Catalog No. (REF) 0065-0826-50, including Custom Paks; b) Vitrectomy Surgery Set (MVS), Catalog No. 8065807101. Recall #Z-490/491-0. CODE Stand alone BSS/+ Administration Set: 105517H, 107061H, 108101H, 109106H, 109175H, 111592H, 111630H, 115025H, 117113H, 118023H, 118980H, 120465H, 121766H, 122469H, 122485H, 124890H, Vitrectomy Surgery Set: 124885H Custom Pak: 115480H, 116288H, 116363H, 116498H, 116572H, 116670H, 116726H, 116895H, 117183H, 117235H, 117391H, 117433H, 117446H, 117451H, 117511H, 117533H, 117597H, 117614H, 117642H, 117644H, 117710H, 117758H, 117834H, 117874H, 117909H, 117910H, 117969H, 117974H, 117975H, 117979H, 118164H, 118230H, 118278H, 118284H, 118346H, 118365H, 118449H, 118508H, 118584H, 118650H, 118815H, 118917H, 119015H, 119017H, 119025H, 119120H, 119121H, 119150H, 119208H, 119282H, 119547H, 119581H, 119650H, 119928H, 120210H, 120235H, 120291H, 120351H, 120362H, 120428H, 120437H, 120439H, 120573H, 120610H, 120643H, 120647H, 120696H, 120704H, 120786H, 120805H, 120822H, 120877H, 120919H, 120967H, 121005H, 121073H, 121165H, 121282H, 121338H, 121348H, 121421H, 121423H, 121429H, 121447H, 121534H, 121654H, 121843H, 121892H, 121899H, 121914H, 122042H, 122377H, 122426H, 122466H, 122694H, 122696H, 122740H, 122854H, 122931H, 122966H, 123192H, 123322H, 123323H, 125391H, 123536H, 123537H, 123608H, 123686H, 123719H, 123840H, 123918H, 123979H, 124183H, 124185H, 124187H, 124377H, 124546H, 124554H, 124606H, 124758H, 124832H, 125006H, 125098H, 125116H, 125118H, 125122H, 125169H, 125181H, 125262H, 125320H, 125323H, 125380H, 125422H, 125522H, 125606H, 125660H, 125841H, 125939H, 125941H, 126003H, 126226H, 126533H, 126577H, 126873H, 127752H, 128158H, 125206H, 128236H, 128364H, 12B365H, 128370H, 128371H, 128380H, 128420H, 128483H, 128485H, 128522H, 128984H, 129398H, 129564H, 131137H, 131138H, 131392H, P124225H, P122487H, P128488H, P125437H, P121813H, P121812H, P113740H, P121811H, P121787H, P123387H, P127721H, P132051H. MANUFACTURER Alcon Laboratories, Inc., Fort Worth, Texas. RECALLED BY Manufacturer, by letter on January 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 33,825 units were distributed from 9/00 to 1/00. REASON An unauthorized change in the filter paper of the filtered-drip chamber that caused the device to have a decreased flow rate. ________ PRODUCT Model No. 250 NeuroCybernetic Prosthesis Programming (NCP) Software, Version 5.0 for use only with the Model No. 100 NCP Pulse Generator and Model No. 200 NCP Programming Wand, an implanted autonomic nerve stimulator implanted for epilepsy. Recall #Z-492-0. CODE All lots. MANUFACTURER Cyberonics, Inc., Houston, Texas. RECALLED BY Manufacturer, by memorandum on August 12, 1998. Firm-initiated field correction complete. DISTRIBUTION Nationwide, South Africa, Belgium. QUANTITY 402 units were distributed; firm estimates none remains on the market. REASON The software contains a flaw that reports an inaccurate amount of remaining battery life for the pulse generator. ________ UPDATE Bio-Laser Systems which appeared in the December 29, 1999 Enforcement is being updated to delete Model TUCO. The recall should read as follows: PRODUCT Bio-Laser System, used for biostimulation: a) Model 1000; b) Model 2000. Recall #Z-281/282-0. CODE Bio-Laser Models 1000 and 2000. MANUFACTURER Bio-Laser Response Corporation, Dr. Alvin Stjernholm, Lakewood, Colorado. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan December 14, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTTY a) 18 models; b) 1 unit. REASON The devices were distributed for human use without a 510(k) or PMA; and failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliances.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Cofield 2 Humeral Stem, 12 mm Diameter Stem 145 mm Length, Catalog #71259012, in sterile packages, for use by an orthopedic surgeon in the treatment of proximal humerus fractures. Recall # Z-493-0. CODE Lot numbers: 81102601 - 81102610. MANUFACTURER Smith and Nephew, Inc., Orthopaedic Division, Memphis, Tennessee. RECALLED BY Manufacturer, by letters on March 13 and 20, 2000, and by fax on March 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, France, Australia, and United Kingdom. QUANTITY 97 units were distributed; firm estimated that 75 units remained on market at time of recall initiation. REASON The device does not have suture holes in the lateral fin. ________ PRODUCT ALYCON Sample Syringe, 50uL used on Alcyon Analyzers 300 and 300i, for in vitro diagnostic tests. Recall #Z-501-0. CODE List Numbers 05D049-02 software used on ALCYON Analyzer List Numbers 04D66-02; 04D67-02; 04D68-02; 04D69-02; 0467-03; 04D69-03. MANUFACTURER Abbott Laboratories, Diagnostics Division, Irving, Texas. RECALLED BY Manufacturer, by telephone between December 22-28, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Hong Kong. QUANTITY 22 units were distributed. REASON Packages labeled and distributed as containing ALYCON Sample Syringe, 50uL contained ALYCON Reagent Syringe, 500uL instead. ________ PRODUCT Roche Reagent for AST [aspartate aminotransferace], in vitro diagnostic reagent system for use on the COBAS MIRA and COBAS FARA chemistry systems for the quantitative determination of the AST. Recall #Z-502-0. CODE Catalog #42381. Lot Numbers: 60642601 EXP 8/00 and 60770501 EXP 11/00. MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana (Distributor), by letter dated March 16, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide QUANTITY Approximately 6,000 kits were distributed. REASON Lots do not meet the stability claim for the working reagent. ________ PRODUCT Total Bilirubin Reagent, Catalog #0737488, for use on the cobas integra 400 and 700 chemistry systems for the quantitative determination of the total bilirubin concentration in blood and plasma. Recall #Z-503-0. CODE Lot #603976-01 EXP 10/00. MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter February 10, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 1,500 kits. REASON Inadequate filling of R1 reagent may cause reporting of falsely lowered total Bilirubin results without warning of incorrect values. ________ PRODUCT SETpoint T Uptake Reference Set for Bayer Immuno 1 System, Catalog #T03-3076-01, a T-Uptake calibrator. Recall #Z-504-0. CODE Lot Numbers: V35454, V37951, V39825. MANUFACTURER Bayer Corporation, Business Group Diagnostics, Middletown Manufacturing Plant, Middletown, Virginia. (NOTE: The Middletown plant has since been sold to Fisher Scientific, Inc. [January 2000] and Fisher will be an OM contractor for this product). RECALLED BY Bayer Corporation, Business Group Diagnostics, Elkhart, Indiana, by letter issued on March 10, 2000. Firm- initiated field correction ongoing DISTRIBUTION Nationwide, Belgium, Canada, France, Germany, Sweden and Switzerland. QUANTITY 758 kits were distributed. REASON Product found to be unstable when shipped or stored per label instructions.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
________ PRODUCT Selenium Premix 4.00%, in 50-pound bags, a trace mineral premix for animal feeds. Recall #V-064-0. CODE Batch 97596 - manufactured 8/16/98. MANUFACTURER Agri-Products, Inc., Milroy, Minnesota. RECALLED BY National Additives, Inc., Liberty, Missouri. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 480 50-pound bags were distributed. REASON Product was subpotent.END OF ENFORCEMENT REPORT FOR APRIL 12, 2000.
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