August 2, 2000 00-31RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Fruit Drinks: Saratoga Smoothies' brand, 16-ounces: a) Banana; b) Mango; c) Peach; d) Strawberry Banana; e) Berry Peach; f) Raspberry; g) Blackberry; Frooja brand, 12-ounces: h) Peach Mango; i) Plentiful C; j) Ginsing Berry; k) Strawberry Banana; l) Fruit Salad; m) Protein Rapture. Recall #F-645/657-0. CODE Enjoy by dates between 5/15/00 and 7/12/00. MANUFACTURER The Fresh Juice Company of Florida, Winter Haven, Florida. RECALLED BY Manufacturer, by telephone, fax, and press release on June 24, 2000, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Products contain undeclared egg and milk protein.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Frozen prepared meals with parboiled rice for institutional use: a) Meat Stuffed Green Peppers with Tomato Sauce, 5-pound 10-ounce container, 12 servings per container; b) Bombay Brand Curry Meal, 45 pieces per container; c) Chicken Suisse Meal a.k.a. Chicken White Cheddar, 45 pieces per container; d) Chicken Kiev Meal, 45 pieces per container. Recall #F-166/169-0. CODE a) Lot date 0610 3/01/00 b) Lot date 0740 3/14/00 c) Lot date 0680 3/08/00 d) Lot dates 0670 3/07/00, 0830 3/23/00, and 0840 3/24/00. MANUFACTURER Culinary Foods, Inc., Chicago, Illinois. RECALLED BY Manufacturer, by telephone on April 11, 2000, followed by fax. Firm- initiated recall complete. DISTRIBUTION Illinois, Minnesota, Washington state, Michigan, New York, Hawaii. QUANTITY 594 cases were distributed. REASON The rice component of the meal was contaminated with pieces of approximately 25-gauge wire ranging from 7-12mm in length. ________ PRODUCT Gold Boy brand Coloured Prawn Crackers, packaged in 227-gram paper box. Recall #F-610-0. CODE None. MANUFACTURER Fushan China Sources (Group) Foodstuffs Corporation, Guangdong, China. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated January 15, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Massachusetts, Florida, Illinois, Pennsylvania, New Jersey, Ohio, Missouri, Virginia, Connecticut, Tennessee. QUANTITY 266 cases (50 boxes per case) were distributed. REASON Product contains the uncertified color additives tartrazine (certifiable as FD&C Yellow No. 5), sunset yellow FCF (certifiable as FD&C Yellow No. 6), and brilliant blue FCF (certifiable as FD&C Blue No. 1); it also contains the unapproved color additive carmoisine. ________ PRODUCT a) Orange Juice in 16-ounce bottles under the following labels: Sunkist, Swiss Dairy, Stater Bros Markets, Knudsen; b) Knudsen brand Lemonade in 16-ounce bottles. Recall #F-612/613-0. CODE The following codes (pull dates) and brands of orange juice and only one code of Knudsen Lemonade are affected: SUNKIST ORANGE JUICE PULL DATE: JULY 22, JULY 17, JULY 15, JULY 10, JULY 09, JULY 08, JULY 03, JULY 02, JULY 01, JUNE 26, JUNE 25, JUNE 19; Swiss Orange Juice PULL DATE: JULY 23, JULY 13, JULY 09, JULY 06, JULY 02; STATER BROTHER ORANGE JUICE PULL DATE: JULY 08 and JUNE 26 KNUDSEN ORANGE JUICE PULL DATE: JULY 22, JULY 17, JULY 07 JULY 15, JULY 13, JULY 09, JULY 06, JULY 05, JULY 01, JUNE 29, JUNE 28, JUNE 24; KNUDSEN LEMONADE PULL DATE: JULY 24. MANUFACTURER Santee Dairies, Inc., City of Industry, California. RECALLED BY Manufacturer, by telephone on June 8 and 13, 2000, followed by letter on June 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Nevada, Hawaii, Utah, Arizona. QUANTITY 27,216 cases of Sunkist OJ; 6,893 cases of Swiss OJ; 1,049 cases of Stater Brothers OJ; 15,828 cases of Knudsen OJ and 6,893 cases of Knudesn Lemonade were distributed. REASON Products may be contaminated with mineral spirits. ________ PRODUCT Fortuner's brand Candy, packaged in 6-ounce plastic bags. Recall #F-632-0. CODE None. MANUFACTURER Undetermined. Product of China. RECALLED BY Fortuner's Food Company, Inc., Brooklyn, New York, by letter and visit on September 10, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 2 cases (100 packages per case) were distributed. REASON Product contained the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT Rainbow Cookies, packaged in 10-ounce clear flexible plastic containers. Recall #F-633-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Gretels Bake Shoppe, New York, New York (bulk cookies). RECALLED BY Delancey Dessert Company, Inc., New York, New York, by letter dated November 16, 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 Undetermined. REASON Product contained undeclared FD&C Yellow No. 5, and FD&C Blue No. 1, and FD&C Red No. 40. ________ PRODUCT Odra brand Mini Fruit Candy, packed in 7.7-pound corrugated box. Recall #F-636-0. CODE All product on the market at time of recall initiation. MANUFACTURER PWC Odra S.A., Brzeg, Poland. RECALLED BY Krasnyi Oktyabr, Inc., USA, Brooklyn, New York, by letter and telephone on June 23, 1999. Completed recall resulted from inspection and follow- up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Oregon, California. QUANTITY 50 cases (7.7 pounds per case) were distributed. REASON Product contains several color additives listed in terms of the European designation for such colors. These colors do not conform to the U.S. color additive regulations as follows: 1) E124 - Ponceau 4R - unapproved color additive 2) E104 - Monosulfonated Quinoline Yellow - not approved for use in food 3) E132 - Indigotine - certifiable as FD&C Blue No. 2, however, the "E" designation suggests the color has not been certified 4) E110 - Sunset Yellow FCF - certifiable as FD&C Yellow No. 6, however, the "E" designation suggests the color has not been certified. ________ PRODUCT Miki Delicatessen brand Malabi Dessert in 8-ounce plastic trays: a) Original Malabi Dessert; b) Strawberries Malabi Dessert. Recall #F- 637/638-0. CODE All Codes. MANUFACTURER Miki Delicatessen Food Products, Fish and Salads, Ltd., Rishon Le Zion, Israel. RECALLED BY Ahava Dairy Products Corporation, Brooklyn, New York, by telephone and visit on March 11, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY a) Approximately 90 cases (12 trays per case); b) Approximately 30 cases (12 trays per case) were distributed. REASON Product contained the unapproved color additive Ponceau 4R and it contained the uncertified color brilliant blue FCF (certifiable as FD&C Blue No. 1). ________ PRODUCT Three Rivers brand Sweet Fennel, packaged in 7-ounce flexible plastic bags. Recall #F-639-0. CODE All product on the market at time of recall initiation. BULK SUPPLIER Sriram Traders Inc., South Plainfield, New Jersey. RECALLED BY Shata Trading, Inc., Brooklyn, New York, by telephone and visit on September 8, 1999. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 175 packages were distributed. REASON Product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 3. ________ PRODUCT Pearl River Bridge brand Coloured Prawn Crackers/Coloured Shrimp Slices, in 8 and 16-ounce cardboard boxes. Recall #F-640-0. CODE None. MANUFACTURER Guangdong Foodstuffs Import and Export Corporation, Guangdong, China. RECALLED BY Blooming Import Company, 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 New York. QUANTITY 44 cases (60 8-ounce packages per case) and 50 cases (50 16-ounce packages per case) were distributed. REASON Product contained the uncertified color additives tartrazine (certifiable as FD&C Yellow No. 5), sunset yellow FCF (certifiable as FD&C Yellow No. 6), and brilliant blue FCF (certifiable as FD&C Blue No. 1); it also contains the unapproved color additives carmoisine and ponceau 4R. _______ PRODUCT Lata brand Mustard Oil, 100% Pure, in 5-fluid ounce bottles (148 ml). Recall #F-644-0. CODE Lot #0324601. MANUFACTURER Bedessee Imports, Ltd., Toronto, Canada (bulk supplier). RECALLED BY Bedessee Imports, Inc., Brooklyn, New York, by telephone on February 22, 1999, followed by visit for relabeling or destruction. Completed field correction resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 612 jars were distributed. REASON The mustard oil is an unapproved food additive.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Tuv Taam brand Olive Spread in 7.5-ounce rigid plastic containers. Recall #F-609-0. CODE All codes on the market at time of recall initiation. MANUFACTURER Tuv Taam Corporation, Brooklyn, New York. RECALLED BY Manufacturer, by letter on February 2, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY Approximately 1,600 containers were distributed. REASON Product contained undeclared sodium benzoate. ________ PRODUCT 3 Diamonds brand Fancy Albacore Solid White Tuna in Water in 6-ounce cans, distributed by Mitsubishi International Corporation, Los Angeles, California. Recall #F-614-0. CODE SWP 3J 36 EHQ. MANUFACTURER Bumble Bee Seafood, Mayaquez, Puerto Rico. RECALLED BY Shaw's Supermarkets, Inc., Bridgewater, Massachusetts (retailer), by E- mail on April 13, 2000, and May 26, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut, Massachusetts, Maine, New Hampshire. QUANTITY 4,189 cans. REASON Product is decomposed. ________ PRODUCT Repackaged infant formula products: a) Isomil Soy Formula with Iron Powder, in 14-ounce cans, 6 cans per case; b) Isomil Soy Formula with Iron Concentrated Liquid, in 13-fluid ounce cans, 24 cans per case; c) Similac with Iron Concentrated Liquid, in 13-fluid ounce cans, 24 cans per case; d) Similac with Low-Iron Powder, in 14-ounce cans, 6 cans per case; e) Similac with Iron Powder, in 14-ounce cans, 6 cans per case; f) Similac Neosure with Iron Powder, in 14-ounce cans, 6 cans per case; g) Enfamil with Low-Iron Powder, in 16-ounce cans, 6 cans per case; h) Enfamil Lactofree Iron Fortified Formula Powder, in 14-ounce cans, 6 cans per case; i) Enfamil with Iron Powder, in 16-ounce cans, 6 cans per case; j) Enfamil Prosobee Iron Fortified Powder, in 14-ounce cans, 6 cans per case; k) Enfamil Nutramigen Iron Fortified Powder, in 16-ounce cans, 6 cans per case. Recall #F-621/631-0. CODE All lots of cardboard cases and trays of infant formula that were repackaged, labeled, and distributed by Unity Wholesale Grocery, Inc. with firm's old address: 753 PINE STREET, and distributed since April 25, 2000. REPACKER Lexington Wholesale Grocery, doing business as Unity Wholesale Grocery, Inc., Lexington, Kentucky. RECALLED BY Repacker, by fax and telephone on June 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Vermont, Connecticut, New York, Michigan, New Jersey, Illinois, Arizona, California. QUANTITY Approximately 2,000 to 3,000 cases were distributed. REASON The infant formulas were repackaged in cardboard trays/boxes which are misbranded. ________ PRODUCT Big K Koolers Sungold Citrus Punch, in 12-fluid ounce cans. Recall #F- 634-0. CODE JUN 07 00 BB. MANUFACTURER Bluefield Beverage Company, Bluefield, Virginia. RECALLED BY The Kroger Company, Cincinnati, Ohio, by fax on June 2, 2000. Completed recall resulted from sample analysis and follow-up by the North Carolina Department of Agriculture. DISTRIBUTION Georgia, South Carolina, North Carolina, Virginia, West Virginia, Ohio, Kentucky, Tennessee, Alabama. QUANTITY 13,723 12-pack cases were distributed. REASON Product may have been contaminated with yeast. ________ PRODUCT Soufi Sweets brand multi ingredient snack products, in 3-1/2 ounce packages: a) Baklawa Pyramid; b) Kunafah. Recall #F-641/642-0. CODE All codes. MANUFACTURER Soufi Sweets, E. Elmhurst, New York. RECALLED BY Manufacturer, by visit on September 27, 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 150 packages of each product were distributed. REASON Products are misbranded because their labels list the ingredient "mixed nuts" when in fact it only contains walnuts.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Dream On (sleep aid), OTC liquid in 16-ounce plastic bottles, marketed and used to enhance sexual activity, improve physicial performance, reduce stress, as a sleep and widely used as a recretional drug. Recall #D-436-0. CODE All lot numbers. MANUFACTURER Undetermined. RECALLED BY J.N.G. Sports Distributors, Bloomburg, Pennsylvania, by letter on April 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,000 bottles were distributed. Firm estimated that very little to no product remained on market at time of recall initiation. REASON Unapproved new drug product: contains GBL (Gamma-Butyrolactone). ________ PRODUCT Tricana (tm) Capsules (Metabolic Hormone Analogue), 1g, in bottles of 90, OTC, marketed as a dietary supplement to treat obesity. Recall #D-437-0. CODE Lot Number 00201, EXP 02/02. MANUFACTURER Undetermined. RECALLED BY J.N.G. Sports Distributors, Bloomburg, Pennsylvania, by letter on April 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 11,359 bottles were; firm estimated that very little to no product remained on the market at time of recall initiation. REASON Unapproved new drug product - Contains tiratricol (Thyroid Hormone). ________ PRODUCT Dimelstat(tm) Capsules, OTC oral dietary supplement in bottles of 60. Recall #D-438-0. CODE Lot #0915, EXP 10/01. MANUFACTURER Phyytos Nutri-Pharma, Corona, California (contract manufacturer). RECALLED BY SciQuest Lab, Inc., Brea, California, by telephone on March 16, 2000, by press release on March 20, 2000, and by letter fax/mailed on March 23, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, California, Connecticut, Florida, Maryland, New Jersey, New Mexico, Washington state and Canada. QUANTITY 953 60-capsule bottles were distributed; firm estimated that 100 bottles of the product remained on market at time of recall initiation. REASON Misbranding: Product fails to declare prescription drug ingredient- glyburide. ________ PRODUCT Dianolyn(tm) Capsules, OTC oral dietary supplement, in bottles of 30. Recall #D-439-0. CODE Lot #0914 EXP 10/02. MANUFACTURER Phyytos Nutri-Pharma, Corona, California. (contract manufacturer). RECALLED BY Diabetic Capital (U.S.) LLC, Alhambra, California (responsible firm), by telephone on March 16, 2000, by press release on March 22, 2000, and by letter on March 24, 2000. Firm-initiated recall complete. DISTRIBUTION California, Florida, Georgia, Kansas, Louisiana, Maryland, Missouri, Oregon, Pennsylvania, Texas, Virginia and the District of Columbia. QUANTITY 10,788 boxes were distributed. REASON Unapproved new drug - Product contains undeclared prescription ingredient, glyburide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Artificial Tears, Polyvinyl Alcohol 1.4%, in 1-fluid ounce bottles, OTC ophthalmic solution, under the following labels: Optopics, Rite Aid, Eckerd, and Nex. Recall #D-440-0. CODE Lot #8I101 EXP 9/01. MANUFACTURER Miza Pharmaceuticals, Inc., doing business as Optopics Laboratories, Fairton, New Jersey. RECALLED BY Manufacturer, by letter on April 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Oregon, Alabama, West Virginia, New York, California, Utah, Florida, Texas, North Carolina, Pennsylvania, Georgia, Michigan. QUANTITY 19,755 bottles were distributed. REASON Lack of assurance of sterility. ________ PRODUCT Clinipad Sterile Alcohol Pads, 100 per plastic bag. (The Clinipad Pads were packaged for a sole customer who then used the pads as a component in kits manufactured by them). Recall #D-441-0. CODE All lots with numbers beginning with 7,8,9,or 0. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut (responsible firm). RECALLED BY Lab Aids, Inc., Ronkonkoma, New York (repacker/distributor), by letter on April 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Wisconsin. QUANTITY 234 packages (100 Clinipad Alcohol Prep Pads per package) were distributed; firm estimated that none of the prep pads remained on market. REASON Lack of assurance of sterility.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-896-0. CODE Unit #16349-5395. MANUFACTURER Blood Systems, Inc., Jackson, Mississippi. RECALLED BY Manufacturer, by telephone on July 30, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Blood product was prepared from an overweight unit of whole blood. ________ PRODUCT Red Blood Cells, Pheresis. Recall #B-917-0. CODE Unit #91S00255 (split unit). MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on December 1, 1999, followed by letter dated December 20, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 split unit was distributed. REASON Blood products were collected from a donor who failed to complete the confidential unit exclusion (CUE) form at the time of donation. ________ PRODUCT Platelets, Pheresis. Recall #B-918-0. CODE Unit #53LT65640. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone and letter on March 2, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT Platelets, Pheresis. Recall #B-941-0. CODE Unit #16245-2701. MANUFACTURER United Blood Services, Hattiesburg, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 9, 1998. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Leukroreduced blood product had an unacceptable white blood cell count. _______ PRODUCT Platelets, Pheresis. Recall #B-950-0. CODE Unit #04LP41266. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on March 6, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit. REASON Blood product, which should have been stored in two bags, was combined into one bag and distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Human T-Lymphotropic Virus Types I and II Abbott HTLV-I/HTLV-II EIA Diagnostic Kit. Recall #B-926-0. CODE Lot 63376M302. MANUFACTURER Abbott Laboratories, Inc., Abbott Diagnostics Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone, followed by letter on June 20, 2000. Firm- initiated recall complete. DISTRIBUTION California, Louisiana, Tennessee, Washington state, Ohio, Illinois, Missouri. QUANTITY 31 kits were distributed. REASON Viral marker test kits exhibited an increased rate of initial reactive test results. ________ PRODUCT a) Gamma-ReACT Pool (Pooled Screening cells) b) Gamma ReACT Duet (Screening cells I & II) c) Gamma-ReACT Trio (Screening cells 1,2,& 3) d) Gamma-ReACT Duet-Plus (Screening cells I & II + Dia antigen) e) Gamma-ReACT Duet-Plus (Screening cells I & II + Cw antigen) f) Gamma-ReACT Trio-Plus (Screening cells 1,2,& 3 + Dia antigen) g) Gamma-ReACT Panel 15. Recall #B-927-0. CODE a) Lot R0314/1; b) Lot R0314/5; c) c) Lot R0314/5 d) Lot R0314/5; e) Lot R0314/5; f) Lot R0314/5 g) Lot R0314/15. MANUFACTURER Gamma Biologicals, Inc., Houston, Texas. RECALLED BY Manufacturer, by letters dated March 23, 2000, and April 3, 2000. Firm- initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 755 units were distributed. REASON Reagent red blood cells, which exhibited false positive reactions during antibody screening and identification.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______ UPDATE Recall #Z-754/755-0, which appeared in the June 28, 2000 Enforcement Report and as an update on July 5, 2000, should read: PRODUCT: SYSMEX CA-1000 and SYSMEX CA-5000 Automated Coagulation Analyzer. MANUFACTURER Sysmex Corporation, Kobe, Japan. RECALLED BY Sysmex Corporation of America, Long Grove, Illinois. END OF ENFORCEMENT REPORT FOR AUGUST 2, 2000. ####
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