July 19, 2000 00-29FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Dried Grouper packed in 7-ounce plastic packages. Recall #F-618-0. CODE None. MANUFACTURER Undetermined, imported from Japan. RECALLED BY Eastern Oceanic Enterprises, Inc., Brooklyn, New York, by telephone, letter, and press release on November 30, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 1 case (50 7-ounce packages) was distributed. REASON PRODUCT, an uneviscerated fish, has the potential to support the growth of and toxin production by Clostridium botulinum.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Baron Creamy Peanut Butter, in 12-ounce jars. Recall #F-600-0. CODE All lots. MANUFACTURER Bajaj Foods, Ltd., Ahmedabad, India. RECALLED BY Universal International, Inc., New Hope, Minnesota, voice mail messages on June 15, 2000. Firm-initiated recall complete. DISTRIBUTION Iowa, Minnesota, Nebraska, New York, North Dakota, Texas, Wisconsin. QUANTITY 1,250 cases, (24 jars per case) were distributed. REASON Product contains 72 ppb of aflatoxin. ________ PRODUCT Kimbo brand of fresh Italian parsley, in 60-count waxed cardboard boxes. Recall #F-602-0. CODE None. MANUFACTURER Ricardo Bravo, Maneadero, Mexico (grower). RECALLED BY F.F. Gonsalez Cilantro Farms Inc., Santa Paula, California (repacker/distributor), by fax on June 14, 2000, and letter on June 16,2000. Firm-initiated recall complete. DISTRIBUTION California, Nevada, Texas, Florida. QUANTITY 1,050 60-count boxes were distributed. REASON Product is contaminated with Shingella. ________ PRODUCT Escolar Fresh Frozen in clear plastic vacuum package, labeled in part: Escolar HG Frozen Thawed. Recall #F-603-0. CODE None. MANUFACTURER Cohan Seafood Company, San Francisco, California (supplier). RECALLED BY Newport Fish Company, South San Francisco, California), by telephone on May 18, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 28 pounds were distributed. REASON The product contained high levels of histamine. ________ PRODUCT Cora brand Chopped Garlic in Water, in 7.5-fluid ounce jars. Recall #F-615-0. CODE None. MANUFACTURER Diva Farms, Ltd., Utica, New York. RECALLED BY Manufacturer, by letter dated April 7, 2000. New York State Department of Agriculture and Markets (NYSDAM) issued press release on April 7, 2000. Completed recall resulted from sample analysis and follow-up by the NYSDAM. DISTRIBUTION New York and Vermont. QUANTITY 45 cases (12 jars per case) were distributed. REASON Product was prepared and packed under insanitary conditions whereby it may have been rendered injurious to health. ________ PRODUCT Don Tomas Parcha Juice, in 16-ounce, 128-ounce, and Concentrate in 12- ounce containers. Recall #F-616/617-0. CODE UPC CODES 16-ounce 012116-000133 64-ounce 012116-56789 128-ounce 012116-01281 12-ounce 012116-09275. MANUFACTURER Don Tomas Foods, Inc., Catano, Puerto Rico. RECALLED BY Carlos Malave & Company, Inc., Catano, Puerto Rico, by visit/notification, followed by letter dated April 6, 2000. Firm- initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY Undetermined. REASON The Parcha juice contains undeclared FD&C Yellow No. 5, FD&C Red No. 40, sodium benzoate, citric acid, and xanthan gum.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Land Oí Lakes Margarine in 1/4-pound sticks, packaged in one-pound retail packages. Recall #F-601-0. CODE 02 16 01 KE10, 02 17 01 KE10, 02 18 01 KE10, 02 19 01 KE10, 02 20 01 KE10. MANUFACTURER Land Oí Lakes, Inc., Kent, Ohio. RECALLED BY Land Oí Lakes, Inc., Arden Hills, Minnesota, by telephone on June 2, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina, Ohio, Pennsylvania, Virginia. QUANTITY 75,480 pounds of margarine were distributed. REASON Product contains metal fragments. ________ PRODUCT Rhizoma Batatatis in 12-ounce and 16-ounce plastic containers. Recall #F-604-0. CODE None. MANUFACTURER Shenzhen Changchun Economic & Trading Company, Shenzhen, Peopleís Republic of China (12-ounce product) Tsang Fook Kee Med. Company, Hong Kong (16-ounce product). RECALLED BY Wah Po Trading, Inc., Brooklyn, New York (importer), by telephone on December 8 & 16, 1998. 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 19 cases (60 12-ounce packages per case) and 20 cases (50 16-ounce packages per case) were distributed. REASON Rhizoma Batatatis contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Tricana(tm) Capsules, 1 mg, in units of 90, Rx for the treatment of obesity and reducing the problem areas of fat. Recall #D-433-0. CODE All lot codes. MANUFACTURER Thermo-Life International, San Carlos, California. RECALLED BY Manufacturer, by letter on April 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 33,203 bottles were distributed. REASON Unapproved new drug.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Glyburide Tablets, USP, (micronized), 6 mg, in 100-tablet bottles, Rx indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type II) whose hyperglycemia cannot be satisfactorily controlled alone. NDC #55370-506- 07. Recall #D-421-0. CODE Lot #ST2343A EXP 9/00. MANUFACTURER MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico. RECALLED BY Manufacturer, by letter on June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 8,407 bottles were distributed. REASON Blend uniformity failure. ________ PRODUCT Leucovorin Calcium Injection, USP, 100 mg (10mg/mL), in 10 mL single dose flip top vial. NDC #0074-4541-02. Recall #D-427-0. CODE Lot #59-387. MANUFACTURER Abbott Laboratories, Abbott Park, Illinois. RECALLED BY Cardinal Distribution, Hudson, Wisconsin (responsible firm), by letter dated June 16, 2000. Firm-initiated recall complete. DISTRIBUTION Minnesota, South Dakota, Iowa. QUANTITY 156 vials were distributed. REASON Product was not stored as labeled-under refrigeration-by distributor (recalling firm). ________ PRODUCT Alcohol Prep Antiseptic Pad in Lovenox(r) ContinuCare(tm) Program AT HOME KITS. (NDC for Clinipad Alcohol Prep is 19154-1254-3). Recall #D-430-0. CODE All lot numbers. MANUFACTURER Aventis Pharmaceutical Products, Collegeville, Pennsylvania. RECALLED BY Manufacturer, by letter dated April 21, 2000, stating that if the individual preferred to keep the kits they need to remove and destroy the Clinipad Alcohol Preps. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Canada, Brazil, France, United Kingdom, Puerto Rico. QUANTITY Firm estimated that 300 kits remained on market at time of recall initiation. REASON Lack of assurance of sterility for the Clinipad Corporation manufactured alcohol prep pads. ________ PRODUCT Meperidine HCl Injection, USP, 75 mg/mL, 1 mL fill in 2 mL tubex(r), Rx. Recall #D-431-0. CODE Lot #2001276 EXP 1/02. MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania. RECALLED BY Manufacturer, by telephone on or about June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Tennessee. QUANTITY 343,124 units were distributed. REASON Lack of assurance of sterility.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Humegon(r) Vial lyophilized powder (memotropins for injection, USP), 2 mL vial, 75 IU, Rx infertility drug. NDC #0052-0300-02. Recall #D-417-0. CODE Lot Numbers: 0990199300, 1000299300, 10103993000, 1020499300, 103599300, 1040699300, and 1050799300. MANUFACTURER Organon, Inc., West Orange, New Jersey. RECALLED BY Manufacturer, by letter dated May 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY Lot # Amount Shipped 0990199300 16,796 units 1000299300 16,524 units 1010399300 16,220 units 1020499300 16,661 units 1030599300 16,638 units 1040699300 16,827 units 1050799300 11,276 units. Note: Each unit consists of five Humegon vials and five 2 mL Sodium Chloride Injection, USP vials. REASON Potency failure (fish component) at stability testing - 30 degrees C). ________ PRODUCT Lanoxin Tablets, 0.125 mg, in bottles of 30 and 100, Rx oral cardiotonic indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation. Recall #D-418-0. CODE Lot Numbers: 9355140, 0006075, and 9354174. MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina. RECALLED BY Allscripts, Inc., Libertyville, Illinois, by letters dated April 17, 2000, and June 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Illinois, Iowa, Wisconsin, Pennsylvania, Arizona, Indiana, Louisiana, Florida, Idaho, Michigan, Hawaii, Maine. QUANTITY 86 bottles of 30 and 19 bottles of 100 tablets were distributed; firm estimated that 30 percent of the product remained on market at time of recall initiation. REASON Tablets do not meet thickness specification and therefore may be subpotent. ________ PRODUCT Atropisol(r) Atropine Sulfate) Ophthalmic Solution 1%, 1 mL, Rx indicated for the treatment of inflammatory conditions of the iris or uveal tract and also as a cyclopegic or mydriatic for refraction. Recall #D-419-0. CODE Lot Numbers and EXP dates: W102 4/00, W103 4/00, W104 5/00, W105 5/00, W106 8/00, X2091 2/00, X2092 3/01, X2093 8/01, X2094 8/01, X2095 8/01, X2096 9/01, X2097 9/01 X2098 9/01 X2099 9/01. MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico (finished product). RECALLED BY CIBA Vision Corporation, San German, Puerto Rico, by letter on May 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 14,665 units were distributed; firm estimated that 3,300 units remained on market at time of recall initiation. REASON Product labeled with incorrect expiration date. ________ PRODUCT Vasosulf(r) Ophthalmic Solution (sulfacetamide sodium 15%-Phenylephrine Hydrochloride 0.125%), Rx indicated for the treatment of conjunctivitis, corneal ulcer, and other superficial ocular infections due to susceptible microorganisms, and an adjunctive in systemic sulfonamide therapy of trachoma. NDC # 58768-883-05 (5 mL); NDC #58768-883-15 (15 mL). Recall #D-420-0. CODE X1095 EXP 1/01, Y1104 EXP 7/00, X1105 EXP 2/01. MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico (finished product). RECALLED BY CIBA Vision Corporation, San German, Puerto Rico, by letter on May 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 19,872 units were distributed; firm estimated that 9,300 units remained on market at time of recall initiation. REASON Failure to revalidate new manufacturing specifications. ________ PRODUCT Triazolam Tablets, USP, 0.125 mg and 0.25 mg, Rx product taken orally as sleeping aid, under the following labels: Par NDC: 49884-453-62 (10x10), 0.125 mg Tablets 49884-453-05 (500), 0.125 mg Tablets Par NDC: 49884-454-62 (10x10), 0.25 mg Tablets 49884-454-05 (500), 0.25 mg Tablets Qualitest NDC: 0603-6186-10 (10x10), 0.125 mg Tablets Qualitest NDC: 0603-6187-10 (10x10), 0.25 mg Tablets. Recall #D-422/423-0. CODE 0.125 mg Tablets: Mfr. Lot# Par Lot# Control# Size EXP Label TE030 013635 014152 10x10 5/2000 Par 014153 10x10 5/2000 Qualitest 014154 500s 5/2000 Par 015617 10x10 5/2000 Par 9B126 017499 017587 500s 2/2001 Par 017589 10x10 2/2001 Par 017590 10x10 2/2001 Par 017591 10x10 2/2001 Par 0.25 mg Tablets: TF064 013730 013871 10x10 6/2000 Par 013872 10x10 6/2000 Qualitest 013874 500s 6/2000 Par 9F200 018698 019113 500s 6/2001 Par. MANUFACTURER Alphapharm Pty Ltd., Carole Park, Old, Australia (bulk tablets). RECALLED BY Par Pharmaceutical, Inc., Spring Valley, New York, by letters on March 14 and 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 0.125 mg: 10x10s total shipped: 4689 units 500s total shipped : 2661 units 0.25 mg: 10x10s total shipped: 6961 units 500s total shipped : 1385 units. REASON Individual impurity specification failure. ________ PRODUCT a) Rubratope(r)-57 Diagnostic Kit (Cyanocobalamin Co 57), Rx, 4 capsules (NDC #0270-3868-10); b) Rubratope(r) Cyanocobalamin Co 57 Capsules, UPS, Rx, 5 and 10 capsules, intended for the diagnosis of pernicious anemia and as a diagnostic adjunct in other defects of intestinal vitamin B12 absorption. NDC #0270-3866-10 and 0270-3866-20. Recall #D-424/425-0. CODE Lot Numbers and EXP dates: UW408681 10/1/99, UW308661 10/1/99, UW308662 10/1/99, UX408681 10/20/99, UX308661 10/20/99, UX308662 10/20/99, UZ408681 1/6/00, UZ408661 1/6/00, UZ408662 1/6/00, WA408681 1/22/00, WA408661 1/22/00, WA418661 1/22/00, WA408662 1/22/00, WD408681 6/5/00, WD418681 6/5/00, WD408661 6/5/00, WD408662 6/5/00, WD508662 6/5/00, WE108681 5/12/00, WE408661 5/12/00, WE308662 5/12/00, WE408662 5/12/00, WG408681 6/19/00, WG408661 6/19/00, WG408662 6/19/00. MANUFACTURER Bristol-Myers Squibb Company, New Brunswick, New Jersey. RECALLED BY Bracco Diagnostics, Inc., Princeton, New Jersey (responsible firm), by field alert letter on May 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10 kits, 10 bottles of 5 capsules, and 20 bottles of 10 capsules were distributed. REASON Incorrect capsule release assay which could lead to a false negative calculation. ________ PRODUCT MediGel H (Topical Hydrocortisone Hydrogel), 1% Hydrocortisone, in 4- ounce plastic bottles, OTC. NDC #57437-7777-04. Recall #D-426-0. CODE Lot No. LMQ. MANUFACTURER Henley Healthcare, Inc., Sugarland, Texas. RECALLED BY Manufacturer, by telephone on or about May 1 to 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 228 bottles were distributed. REASON Super-potent. ________ PRODUCT Vicoprofen(r) Tablets (hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg), in 500-count bottles, Rx. NDC #0044-723-03. Recall #D-428-0. CODE Lot #0000060685 EXP 10/01. MANUFACTURER Knoll Pharmaceutical Company, Whippahy, New Jersey. RECALLED BY Knoll Pharmaceutical Company, Mt. Olive, New Jersey, by letter on April 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 3,475 bottles were distributed. REASON Misbranded - Some bottles have partially illegible lot numbers and/or expiration dates. ________ PRODUCT IBU(r) Tablets (Ibuprofen), 800 mg, in 500-count bottles, Rx non- steroidal anti-inflammatory agent. Par NDC #49884-469-05. Recall #D-429-0. CODE Lot #20692 EXP 11/00. MANUFACTURER BASF Corporation, Shreveport, Louisiana. RECALLED BY Manufacturer, by telephone on May 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,279 bottles were distributed. REASON Product exceeds impurity specification at 18-month stability (4- isobutylacetophenone). ________ PRODUCT Aspirin Tablets, 325 mg, in units of 2, 100, and 300, Rx under the following labels: Pharmacist Formula (2 tablets); Albertson (100 count); and Target (300 count). Recall #D-432-0. CODE Lot #8M00476 EXP 10/01. MANUFACTURER Leiner Health Products, Inc., Kalamazoo, Michigan. RECALLED BY Leiner Health Products, Inc., Carson, California, by letter faxed on May 2, 2000, followed by mail on May 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Idaho, Hawaii, Illinois, Maryland, Minnesota, Texas, Virginia. QUANTITY 47,832 10-tablet bottles; 9,276 300-count bottles and 5,424 boxes 100 tablet blisters were distributed. REASON Dissolution failure (24 month stability).RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Bivona FlexTend Plus Pediatric Cuffless Tracheostomy Tube. Recall #Z-857-0. CODE Catalog #60PFP45, Lot #888100. MANUFACTURER Bivona Medical Technologies, Gary, Indiana. RECALLED BY Manufacturer, by telephone between April 27, 2000, and May 4, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY 47 units were distributed. REASON A package contained a standard FlexTend Tube. ________ PRODUCT Sterostatic Neurosurgery Planning System, SteroPlan 2.0 and SteroPlan 2.1. Recall #Z-858-0. CODE Catalog No. STERO-SW-2. MANUFACTURER Radionics, Burlington, Massachusetts. RECALLED BY Manufacturer, by telephone on May 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 44 units were distributed. REASON position errors up to 2.5 mm may be observed if the user removes a slice from a CT or MRI image after the image has been fused and a fusion matrix has been generated. ________ PRODUCT Healthdyne SmartMonitor series Infant Apnea Monitors. Recall #Z-861-0. CODE Catalog Numbers - 900S, 900S-02, 900S-02-01, 900S-02-04, 900S-02-07, 900SL, 970S, 970S-02, 970S-02-01, 970SE, 970SE-02, 970SE-02-04, 970SE-02- 07. Note: serial numbers relate to year and month. A-L=January- December; first numerical character defines year, 5-9=1995-1999. This recall involves all type 3A and 3B SmartMonitors Infant Apnea Monitors manufactured between 12/1/95 to 1/15/2000. MANUFACTURER Respironics, Inc., Marietta, Georgia. RECALLED BY Manufacturer, by distributing field correction kits to all customers on March 29, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 28,000 units were distributed. REASON The electrical circuit on the display printed circuit board can become damaged. ________ PRODUCT Medtronic AneuRx Stent Graft System, designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms using an endovascular approach. Recall #Z-862-0. CODE Catalog Number Tapered Tip Reusable Handle YREC1855 NA YREC20375 PD03140-20 YREC22375 PD03140-22 YREC24375 PD03140-24 YREC26375 PD03140-26 YREC28375 PD03140-28 YREC31375 NA YRBR2012135 PD03138-20 YRBR2213135 PD03138-22 YRBR2414135 PD03138-24 YRBR2615135 PD03138-26 YRBR2816135 PD03138-28 YRBR3116135 NA YRBR2012165 PD03139-20 YRBR2213165 PD03139-22 YRBR2414165 PD03139-24 YRBR2615165 PD03139-26 YRBR2816165 PD03139-28 YRBR3116165 NA Catalog Number IDS YRDEC1855 PD02457-18 YRDEC20375 PD02457-20 YRDEC22375 PD02457-22 YRDEC24375 PD02457-24 YRDEC26375 PD02457-26 YRDEC28375 PD02457-28 YRDEC31375 PD02457-31 YRDBR2012135 PD02087-20 YRDBR2213135 PD02087-22 YRDBR2414135 PD02087-24 YRDBR2615135 PD02087-26 YRDBR2816135 PD02087-28 YRDBR3116135 PD02087-31 YRDBR2012165 PD02086-20 YRDBR2213165 PD02086-22 YRDBR2414165 PD02086-24 YRDBR2615165 PD02086-26 YRDBR2816165 PD02086-28 YRDBR3116165 PD02086-31 MANUFACTURER Medtronic, Inc., Minneapolis, Indiana. RECALLED BY Medtronic AVE, Santa Rosa, California, by letter on June 13, 2000, and by visit. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 230 units were distributed. REASON Product has the potential for detachment of a 21F-tapered tip nosecone from the catheter. ________ PRODUCT Merit Majestic Series, angiographic needle: a) Catalog No: AN19U31W; b) Catalog No. AN19U71W; c) Catalog No. K10-01394P. Recall #Z-863/864-0. CODE Lot Numbers: a) A133547 and A140201; b) A131089, A133549, and A138174; c) A129650 and A134029. MANUFACTURER Merit Medical Systems, Inc., South Jordan, Utah. RECALLED BY Manufacturer, by visit beginning March 3, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, France. QUANTITY 1,929 units were distributed. REASON The needle hub may be brittle and could fracture during use.SEIZURE ACTIONS:============================================
________ PRODUCT Dietary Supplements (Z23, Opti-Cran, Vitamin C (& Ginseng coated), Garlic, Uva Ursi, Saw Palmetto, Ginkgo Biloba, St. John's Wort). (1812- 1817, 48978/80 & 5071/5075, and 82623-82630). CHARGES New Drug and Misbranded - Products are unapproved new drugs represented as dietary supplements and they fail to bear adequate directions for use. LOCATION Hillestad Pharmaceuticals, Woodruff, Wisconsin. FILED May 3, 2000 - U.S. District for the Western District of Wisconsin. Civil #00C02625; FDC #67294. SEIZED May 17, 2000 - Goods approximately 376 cases valued at $500,999 and bulk tablets valued at $79,000. ________ PRODUCT T3 Metabolite (730). CHARGES New drug, misbranded, and alternative food, adulterated - Product is an unapproved new drug represented as dietary supplement, which fails to bear adequate directions for use. Alternative food charges-risk of illness or injury, poisonous or deleterious. LOCATION One World Fulfillment Distribution, Inc., Mobridge, South Dakota. FILED June 1, 2000 - U.S. District Court for the District of South Dakota, Northern Division. Civil #CIV00-1015; FDC #67405. SEIZED June 8, 2000 - 927 bottles valued $32,400. END OF ENFORCEMENT REPORT FOR JULY 19, 2000. ####
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