May 24, 2000 00-21RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Fresh Strawberries, in bulk cardboard cartons labeled under the Fresh Delight and Janina-V/ Janina-1st brand labels. Recall #F-460-0. CODE All strawberries associated with import entry #748-0185065-7. GROWER Rancho La Vaneza Sri De CV, Vincente Guerrero, Baja, California, Mexico. RECALLED BY Expo Fresh LLC, San Diego, California, by letter faxed or mailed on March 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Arizona, Michigan, Missouri. QUANTITY 915 cartons consisting of 12,810 pounds were distributed. REASON Product is contaminated with salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Frozen Strawberries: a) Richfoods brand Frozen Sliced Strawberries, packed in 16oz., fibermatic container Sysco Classic brand Frozen Sliced Strawberries. Packed in 30-lb. plastic pail Alliant Prestige brand Frozen Sliced Strawberries, packed in 6 1/2-lb. plastic tub. Great Value brand Frozen Sliced Strawberries, packed in 10 oz. sefton container Safeway brand Frozen Sliced Strawberries, packed in 16 oz. fibermatic container Kroger brand Frozen Sliced Strawberries, packed in 10 oz. fibermatic container Kroger brand Frozen Sliced Strawberries, packed in 16 oz. fibermatic container b) Sysco Classic brand Frozen Whole Strawberries packed in 30-lb plastic pail c) New West Foods brand Frozen Juice Stock Strawberries, packed in 400-lb. Drum. Recall #F-457/459-0. CODE NW060991 and NW063094. MANUFACTURER New West Foods, Watsonville, California. RECALLED BY Manufacturer, by letters, telephone, faxes and overnight deliveries beginning on April 25, 2000, and by press release on April 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (1) Richfoods brand Frozen Strawberries, packed in 16 oz. Fibermatic container: 24 packages per case. Code: NW063094 441 cases processed and shipped on 9/7/99, 1/12/00, 3/21/00 (2) Sysco Classic brand Frozen Sliced Strawberries packed in 30-lb. plastic pail, Code: NW063094. 588 pails processed and shipped on 4/14/00, ***4/22/00*** (3) Sysco Classic brand Frozen Whole Strawberries packed in 30-lb. plastic pail, Code: NW060991. 192 pails all remaining at the firm (4) Alliant Prestige brand Frozen Strawberries, packed in 6 1/2-lb. plastic tub, 6-lb. tubs per case. Code: NW063094, NW060991. 905 cases processed, 862 cases shipped, 43 cases remain at firm (5) Great Value brand Frozen Sliced Strawberries, packed in 10 oz. Sefton container, 24 packages per case. Code: NW063094. 171 cases processed, 46 cases shipped, 125 cases remaining at the firm (6) Safeway brand Frozen Sliced Strawberries, packed in 16 oz. Sefton container, 24 packages per case. Code: NW060991. 189 cases processed, 160 cases shipped on 12/28/99, 29 cases remain at the firm (7) Kroger brand Frozen Sliced Strawberries, packed in 10 oz. Fibermatic container, 24 packages per case. Code: NW060991. 154 cases processed, 154 cases shipped on 6/25/99 to 8/19/99 (8) Kroger brand Frozen Sliced Strawberries, packed in 16 oz. Fibermatic container, 24 packages per case. Code: NW060991. 328 cases processed, 328 shipped (9) New West Foods brand Frozen Juice Stock Strawberries, packed in 400-lb. drum, Code: NW063094. 3 drums all remaining at the firm. REASON Product was associated with a March 2000 illness outbreak of hepatitis A in Massachusetts.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_________ PRODUCT a) Chocolate Covered Peanut Butter Cookies, in 5-pound package; b) Cinnamon Pecan Crescent Cookies, in 5-pound package; c) Easter Assortment Cookies, in 5-pound package. Recall #F-453/455-0. CODE All lots. MANUFACTURER Pati Petite Cookies, Inc., Bridgeville, Pennsylvania. RECALLED BY Manufacturer, by letter on April 20, 2000. Ongoing field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Pennsylvania, Maryland, Texas, Ohio, Canada. QUANTITY 24 cases were distributed. REASON Cookies contain a) undeclared peanuts; b) undeclared pecans; c) undeclared peanuts, pecans, and almonds.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
________ PRODUCT Foam Burst Moisturizing Body Wash, in 6.8 ounce canisters, in the following fragrances: Sun-Ripened Raspberry, Country Apple, Freesia, Plumeria, Juniper Breeze, Cucumber Melon, Pearberry, Daffodil Fields, Lavender Flowers, Tangerine Spice, Sparkling Green Apple. Canisters are sold individually and/or in gift set baskets. Recall #F-456-0. CODE All product codes manufactured between 7/10/99 and 12/31/99. The recalled product was manufactured between 7/10/99 and 12/31/99. The first three digits of the Product Code represent the Julian date of manufacture. This code is embossed on the bottom of each can. An example of the code breakdown is as follows: 23397UA2 = 233 = Julian date of manufacture 9 = Year code (9 = 1999) 7U = Vendor code A = Time the product was filled (A is first day, B is second day) 2 = The shift that filled the product SKU Number Description 55128597 Raspberry 55128607 Country Apple 55128610 Freesia 55128623 Plumeria 55128636 Juniper Breeze 55128649 Cucumber Melon 55128652 Pearberry 55128664 Daffodil 55147086 Lavender Fields 55147099 Tangerine Spice 55128678 Sparkling Green Apple 58129069 Large Shaker Slat Basket, Cucumber Melon 58129098 Large Braided Wicker Basket, Assorted Flavors 58141319 Square Lined Wire Basket, Cucumber Melon and Freesia. MANUFACTURER Aerosols International, Wellington, UK. RECALLED BY Bath & Body Works, Reynoldsburg, Ohio (distributor/responsible firm), by E-mail on April 27, 2000, by letter on April 28, 2000, and by press release on May 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 1.5 million canisters were sold since 9/20/99. REASON Potential for ocular injuries from inadvertent spraying of Foam Burst Body Wash into the eyes.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Feosol(r) Elixir Iron Supplement Therapy 44mg, in 16-ounce (473ml) bottles. Recall #D- 347-0. CODE Lot Numbers: 9H23A and 9J11A. MANUFACTURER SmithKline Beecham Consumer Healthcare, Aiken, South Carolina. RECALLED BY SmithKline Beecham Consumer Healthcare, Parsippany, New York, by letter and public warning on February 18, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 884 cases (12 bottles per case) were distributed. REASON Subpotent iron content (stability testing) and crystalline precipitate. __________ PRODUCT Albuterol Sulfate Inhalation Solution, 0.083%, in 3 ml unit dose vials, Rx used for the prevention and relief of bronchospasm. NDC# 0472-0831-60. Recall #D-348-0. CODE Lot #A9H045 EXP 8/01. MANUFACTURER Automatic Liquid Packaging, Woodstock, Illinois. RECALLED BY Alpharma USPD Inc., Baltimore, Maryland, by letter on March 3, 2000. Firm-initiated recall complete. DISTRIBUTION New York and Missouri. QUANTITY 2,340 vials were distributed; firm estimates none remains on the market. REASON Mislabeling - Exterior holding carton incorrectly labeled as Ipratropium (vials inside correctly labeled). ________ PRODUCT Jordan Epinephrine Injection, USP, 1:1000, 1 mg/mL, 1mL ampuls, Rx sterile solution intended for subcutaneous or intramuscular administration for the treatment of respiratory distress in bronchial asthma or during severe, acute asthma attacks, severe anaphylactic reactions and shock, and cardiac arrest to restore cardiac rhythm. NDC #58196-065-31. Recall #D-349-0. CODE Lot Numbers: 980308, 980401, 980402, 980501, 980601, 990205, 990307, 990308. MANUFACTURER Bioniche Teo, Republic of Ireland. RECALLED BY Jordan Pharmaceuticals Inc., Elk Grove Village, Illinois, by letter dated March 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, Mississippi, California. QUANTITY 2,167 100-ampule boxes were distributed. REASON Subpotency - During stability testing. ________ PRODUCT Mintezol(r) Chewable (Thiabendazole) Tablets, USP, 500 mg, in unit dose packages of 36 tablets, Rx for the treatment of parasitic infections. Recall #D-352-0. CODE Lot Numbers and EXP Dates: J800 EXP Jan 04, J8001 EXP Jan 04, J8002 EXP Jan 04, J8003 EXP Jan 04, J8004 EXP Jan 04, J8005 EXP Jan 04, J8011 EXP Feb 04, J8012 EXP Feb 04, J8013 EXP Mar 04, J8014 EXP Feb 04, J8016 EXP Feb 04, J8017 EXP Feb 04. MANUFACTURER Merck and Company, West Point, Pennsylvania. RECALLED BY Manufacturer, by letter dated March 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 24,163 units were distributed. REASON Use of an unapproved binding agent was used in formulation. ________ PRODUCT True Care(tm) Stool Softener with Laxative Softgels, (Docusate Sodium 100 mg/Casanthranol 30 mg), OTC in bottles of 100. NDC #57394-254-52. Recall #D-354-0. CODE Lot numbers: 5674A, 5765B, and 5834A. MANUFACTURER Banner Pharmacaps, High Point, North Carolina. RECALLED BY Apothecary Products, Inc., Burnsville, Minnesota, by telephone on March 9, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 1,584 bottles were distributed. REASON Misbranded - Labeling fails to declare dosage instructions. ________ PRODUCT Saline Nasal Spray, OTC, in 1.5-ounce white bottles, under the following labels: Albertson’s, Bi-Mart and Health Pride. Recall #D-355-0. CODE Lot number: 9M97007. MANUFACTURER Accupac, Inc., Mainland, Pennsylvania. RECALLED BY Leiner Health Products Inc., Carson, California, by letter dated February 15, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana, Oklahoma, Oregon, Pennsylvania. QUANTITY 30,732 units were distributed. REASON Products had discoloration and iron contamination. ________ PRODUCT Meperidine HCL Injection, USP, Rx for relief of moderate to severe pain, for pre-operative medication, for support on anesthesia, and for obstetrical analgesia: a) 50 mg/mL in 30mL vial, NDC #0008-0258-01; b) 100 mg/mL in 20 mL vial, NDC #0008-0259-01. Recall #D-356/357-0. CODE Lot numbers: a) 4970174 EXP 11/00, 4980176 EXP 6/01, 4980216 EXP 7/01, 4990104 EXP 2/02; b) 4970175 EXP 11/00, 4980213 EXP 6/01, 4980214 EXP 9/01, 4990084 EXP 3/02. MANUFACTURER Wyeth Laboratories, Marietta, Pennsylvania. RECALLED BY Wyeth Ayerst Laboratories, St. Davids, Pennsylvania, by letter dated March 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 95,786 vials were distributed. REASON Lack of assurance of sterility. ________ PRODUCT Spartan(r) Antiseptic Hand Cleaner, Hair & Shampoo, OTC, in 800 mL bags, 1 and 5-gallon pails, and 15, 30 and 55-gallon drums. Recall #D-363-0. CODE Lot Numbers: 0987 through 0993, and all codes prior to "04/03/00" expiration date. MANUFACTURER Steiner Company, Inc., Holland, Ohio (packager). RECALLED BY Spartan Chemical Company, Maumee, Ohio (responsible firm), by letter on April 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 100,800 gallons were distributed. REASON Product contains unapproved dyes. ________ PRODUCT Americair brand Oxygen Compressed, USP medical gas in high-pressure cylinders sizes E, D, C and B, Rx for pulmonary use as directed by a physician for Oxygen deficiency or emergency resuscitation. Recall #D-365-0. CODE All lot numbers including all tanks received by customers between 4/97 through 4/7/00. MANUFACTURER Americair of the East Bay, Vacaville, California. RECALLED BY Manufacturer, by visit on April 7, 2000, by letter mailed on April 12, 2000, and by press release faxed on April 7, 2000. Firm- initiated recall complete. DISTRIBUTION California. QUANTITY Approximately 2,500 cylinders were distributed. REASON Current good manufacturing deviations including but not limited to lack of odor testing prior to distribution. ________ PRODUCT Copaxone(r) (glatiramer acetate for injection, formerly known as Copolymer-1) Self Injection Administration package containing 100 units of Alcohol Prep (Swab) recalled by Clinipad Corporation. Recall #D-366-0. CODE The Clinipad lot numbers that had been packaged into the kits were: 803902 812094 812879 814063 910806 814314 915860 805963 812158 813314 814747 910089 915435 916061 805829 811229 813550 815368 910599 915110 916415 805206 812091 813313 815970 910594 915461 915937 809016 811658 803206 910559 910093 915860 915504 809018 812878 800521 910089 911739 915728 917479 809019 814065 910092 911313 917040. COMPONENT MANUFACTURER The Clinipad Corporation, Charlotte, North Carolina (responsible firm). RECALLED BY Aventis Pharmaceuticals, Inc., Kansas City, (distributor), by fax and letter dated March 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 376,689 administration kits were distributed between 3/19/97 through 3/13/2000. REASON Administration kits contain alcohol preps for which Clinipad Company is unable to assure the sterility. ________ PRODUCT Goldline Brand: a) Doxycycline Hyclate Capsules, 100 mg, in blister packs in boxes of 100; b) Indomethacin Capsules, 50 mg, in blister packs in boxes of 100. Recall #D-367/368-0. CODE Lot Numbers: a) T-1474 EXP 10/01; b) T-1475 EXP 10/01. MANUFACTURER Zenith Goldline Pharmaceuticals, Northvale, New Jersey. International Labs, St. Petersburg, Florida (responsible repacker/packager (contract)). RECALLED BY Zenith Goldline Pharmaceuticals, Miami, Florida, by letter beginning on April 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 604 boxes; b) 366 boxes were distributed; firm estimated that 50 percent of the product remained on market at time of recall initiation. REASON Mislabeling - Indomethacin Capsules were incorrectly labeled as Doxycycline Hyclate Capsules. ________ UPDATE Rugby Hemorrhoid Preparation Suppositories in cardboard box containing 12 suppositories, Recall #D-113-0, which appeared in the December 15, 1999 Enforcement Report has been extended to include Lot #908222.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Promethazine with Codeine Cough Syrup (6.25 mg/5 mL and 10 mg/5 mL), in 4 and 16-fluid ounce (pint) bottles, Rx schedule V narcotic oral liquid for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold, under the following labels: a) MGP, 4-ounce - NDC #60432-606-04 and 16-ounce - NDC #60432-606-16 b) Zenith Goldline, 16-ounce - NDC #0182-1712-40 c) Major Pharmaceuticals, 4-ounce - NDC #0904-1510-00 and 16-ounce - NDC #0904-1510-16 d) Qualitest, 4-ounce - NDC #0603-1578-54 and 16-ounce - NDC #0603-1578-58 e) URL, 16-ounce - NDC #0677-0963-33. Recall #D-340-0. CODE Lot Numbers: 22128, 22161, 22238, 22295, 22369, 22500, 22555. MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois. RECALLED BY Manufacturer, by letter dated March 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 54,587 4-ounce bottles and 172,512 16-ounce bottles were distributed; firm estimated that less than 20% of the product remained on market at time of recall initiation. REASON Subpotency of the Promethazine Hydrochloride ingredient. ________ PRODUCT Clindamycin Phosphate Topical Solution USP, 1%, Rx, packaged in 1-fluid ounce bottles - NDC #60432-693-30 and 2-fluid ounce bottles - NDC #60432-693-60. Recall #D-341-0. CODE Lot Numbers: 21796 and 22334. MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois. RECALLED BY Manufacturer, by letter dated April 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,273 1-ounce bottles and 2,966 2-ounce bottles were distributed; firm estimated that less than 20 percent of the product remained on market at time of recall initiation. REASON One degradant exceeded specification during stability testing. ________ PRODUCT Promethazine VC Plain Syrup, (6.25mg/5mL and 5 mg/5mL), in 4-ounce and 16-ounce (pint) bottles, an Rx oral liquid intended for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold, distributed under the following labels: a) MGP, 4-ounce - NDC #60432-605-04, 16-ounce - NDC #60432-605-16 b) Major Pharmaceuticals, 16-ounce - NDC #0904-1512-16 c) Qualitest, 4-ounce - NDC #0603-1582-54, 16-unce - NDC #0603-1582-58. Recall #D-342-0. CODE Lot 22110 (sublots A,C,E) EXP 04/00 and lot 22227(sublots A,C,E,F,H,K) EXP 06/00. MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois. RECALLED BY Manufacturer, by letter dated May 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,618 4-ounce bottles and 29,038 16-ounce bottles were distributed; firm estimated that less than 10 percent of the product remained on market at time of recall initiation. REASON Subpotency of the Promethazine Hydrochloride ingredient. ________ PRODUCT Triamcinolone Acetonide Cream USP, 0.1%, in 15-gram tubes, Rx. NDC #49159-140-20. Recall #D-343-0. CODE Lot #M793 EXP 3/03. MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York. RECALLED BY Manufacturer, by letter dated March 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, California, Michigan, New York, Georgia, Colorado, Connecticut, North Carolina, Arkansas, Hawaii. QUANTITY 30,000 units were distributed. REASON Mispackaging - Some of the tubes are incorrectly labeled to contain Gentamicin Sulfate. ________ PRODUCT Dimethyl Sulfoxide, USP Grade DMSO (active ingredient bulk), 500 mL and 1 liter amber glass bottles, Rx. Recall #D-344-0. CODE Lot Numbers: USP990614, USP990727, and USP990817. MANUFACTURER Gaylord Chemical Corporation, Bogalusa, Louisiana. RECALLED BY Manufacturer, by letter dated February 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 96 liters (232 pounds) of material in 500 mL and 1-liter amber glass bottles were distributed. REASON Package integrity/product leakage. ________ PRODUCT Lorazepam Injection, USP, 4 mg/ml, in 10 mL multiple dose vial (NDC #0074-1539-10) and 1 mL Carpujec(r)/needle prefilled syringe (NDC #0074-1539-11), Rx for preanesthetic medication of adult patients to produce sedation, relief of anxiety and a decreased ability to recall events related to the day of surgery. Recall #D-345-0. CODE Lot Numbers: 44-635-3B, 49-650-3B, 46-315-3A MANUFACTURER Abbott Laboratories, Inc., McPherson, Kansas. RECALLED BY Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois, by letter dated March 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 55,750 1-mL syringes and 2,392 10-mL vials were distributed. Firm estimated that less than 5,000 -1-mL syringes and 1,500 10-mL vials remained on the market at time of recall initiation. REASON Mislabeling - Incorrect drug concentration declared (2 mg lorazepam). (Drug title correctly cites 4 mg/ml). ________ PRODUCT Tavist-D(r) Tablets, (Clemastine Fumarate, USP 1.34 mg/ Phenylpropanolamine HCL 75mg), 8 tablet units, OTC, antihistamine/nasal decongestant. NDC #0067-0122-08. Recall #D-346-0. CODE Lot #306295 EXP 3/02. MANUFACTURER Novartis Consumer Health, Inc., Lincoln, Nebraska. RECALLED BY Manufacturer, by letter on February 16, 2000. Firm-initiated recall complete. DISTRIBUTION Nebraska and Indiana. QUANTITY 345,780 packages were distributed. REASON Low weight tablets. ________ PRODUCT Morphine Sulfate Injection, USP, 10 mg/mL, in 1 mL dosette(r) ampule, Rx potent analgesic. NDC #10019-178-68. Recall #D-351-0. CODE Lot #099077 EXP 9/02. MANUFACTURER ESI-Lederle, Cherry Hill, New Jersey. RECALLED BY Baxter Pharmaceutical Products, Inc., New Providence, New Jersey, by letter February 23, 2000. Firm-initiated recall complete DISTRIBUTION Nationwide. QUANTITY 113,750 ampuls were distributed; firm estimated that 3,657 ampuls remained on market at time of recall initiation. REASON Mislabeled - Label incorrectly declares strength as (1/8 gr per mL) not (1/6 gr per mL). ________ PRODUCT Urecholine(r) Injection (Bethanechol Chloride), 5.15 mg/mL, 1 mL injection, Rx for the treatment of acute post-operative/post- partum non-obstructive urinary retention, and for neurogenic atony of urinary bladder with retention. NDC #07786-29-00. Recall #D-358-0. CODE Lot Numbers: 0019E EXP 3/01, 0947E EXP 3/01, 0327J EXP 8/01, 0346J EXP 8/01, 1323J EXP 8/01, 1324J EXP 8/01, 1374H EXP 8/01, 1606H EXP 8/01, 1898H EXP 8/01. MANUFACTURER Merck and Company, Inc., West Point, Pennsylvania. RECALLED BY Manufacturer, by letter dated March 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, France, Australia, Italy, Sweden, Lebanon, South Africa. QUANTITY 20,858 units were distributed; firm estimated that 600 units remained on market at time of recall initiation. REASON pH failure (at stability testing). ________ PRODUCT Lanoxin(r) Tablets (digoxin), 0.125mg, in bottles of 1,000, Rx indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation. NDC #0173-0242-075. Recall #D-359-0. CODE Lot #9ZP1665 EXP 6/02. MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina. RECALLED BY Manufacturer, by letter on March 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Connecticut, Florida, Georgia, Massachusetts, Maryland, Maine, Mississippi, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia, Puerto Rico. QUANTITY Firm estimated that 22,639 bottles remained on market at time of recall initiation. REASON Tablet thickness failure. ________ PRODUCT Digoxin Tablets, 0.125 mg, repacked in unit dose blister packs (10x31) with and without a grid card, Rx indicated for the treatment of mild to moderate heart failure, and for the control of ventricular response rate in patients with chronic atrial fibrillation. NDC #00615-0547-63 (uncarded) and NDC #00615-0547-53 (carded). Recall #D-360-0. CODE Lot #0547-0003 EXP 1/31/01. MANUFACTURER Glaxco Wellcome, Inc., Research Triangel Park, North Carolina (responsible firm). RECALLED BY NCS Health Care of KY, doing business as Vangard Labs, Inc., Glasgow, Kentucky (repacker/distributor), by letter on April 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, Massachusetts, Illinois, New York, Tennessee, North Carolina, California, Vermont, Maryland, Ohio, Maine. QUANTITY 90 blister pack units were distributed. REASON Tablet thickness failure. ________ PRODUCT Oxygen USP, Rx in E, D, and M-6 Compressed Cylinders. Recall #D-361-0. CODE E cylinders, coded 0260001 and 0260002 D cylinders, coded 0260002 M-6 cylinders coded 0260002. MANUFACTURER Southern Respiratory, Inc., Naples, Florida. RECALLED BY Manufacturer, by telephone on February 10-11, 2000. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 21 E cylinders, 6 D cylinders and 3 M-6 cylinders were distributed. REASON Current good manufacturing deviations and complaint related to "chlorine-like odor". ________ PRODUCT Vancomycin Hydrochloride, USP, Sterile, 10 g, in pharmacy bulk package, Rx for IV Infusion after dilution. NDC #0469-3140-61. Recall #D-362-0. CODE Lot Numbers: 180266, 180432, 180449, 180465, 180490, 180635, 180647, 180693. MANUFACTURER American Pharmaceutical Partners, Inc., formerly known as Fujisawa USA, Melrose Park, Illinois. RECALLED BY American Pharmaceutical Partners, Inc., Melrose Park, Illinois, by letter dated April 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 44,006 100-mL vials were distributed. Firm estimated that 20 percent of the product remained on market at time of recall initiation. REASON Moisture failure during stability testing. ________ PRODUCT Estrostep(r) Fe Tablets, (norethindrone acetate, ethinyl estradiol and ferrous fumarate), in 28 tablet dispensers, Rx oral contraceptive. NDC #0071-0928-47. Recall #D-364-0. CODE Lot Numbers: 44808F EXP 3/00, 44908F EXP 3/00, and 44708F (Expired 2/00). MANUFACTURER Warner Lambert, Fajardo, Puerto Rico. RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by UPS ground tracking service on February 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 29,703 units were distributed; firm estimated a minimal amount remained on market at time of recall initiation. REASON Subpotency (at 12 month stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-623-0. CODE Unit #LS08403. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated May 14, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT Platelets. Recall #B-625-0. CODE Unit 24KL36651. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by telephone on February 4, 2000, and by letter dated February 9, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Drug product was collected from a donor taking the drug Plavix (clopidogrel bisulfate). ________ PRODUCT Source Plasma. Recall #B-626-0. CODE Unit Numbers: 07065316, 07063206, 07028885. MANUFACTURER Sera-Tec Biologicals, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, by letter dated January 6, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Source Plasma. Recall #B-627-0. CODE Unit #11355748. MANUFACTURER Sera-Tec Biologicals, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 15, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who tested reactive for syphilis within two days of donation. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-628-0. CODE Unit #21KE07861. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 21, 2000. Firm-initiated recall complete. DISTRIBUTION Georgia. 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 Red Blood Cells. Recall #B-629-0. CODE Unit #21Y57701. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 21, 2000. Firm-initiated recall complete. DISTRIBUTION California. 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 Red Blood Cells, Leukocytes Reduced. Recall #B-630-0. CODE Unit #18222-3483. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 14, 2000, and by letter dated March 29, 2000. Firm-initiated recall complete. DISTRIBUTION Wyoming. QUANTITY 1 unit was distributed. REASON Blood product was mislabeled as CMV antibody negative. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-631/633-0. CODE Unit Numbers: a) 056J51046, 056K26775, 056K16228, 056G21567 b) 056K26775, 056G21567; c) 056J51046, 056K16228, 056G21567 MANUFACTURER American Red Cross Blood Services, Albany, New York. RECALLED BY Manufacturer, by letters dated August 19, 25, or 30, 1999, and November 5, 1999. Firm-initiated recall complete. DISTRIBUTION New York, North Carolina, California. QUANTITY a) 4 units; b) 2 units; c) 3 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-634/636-0. CODE Unit Numbers: a) 23028-7086, 23139-1030; b) 23028-7086; c) 23028-7086, 23139-1030. MANUFACTURER United Blood Services, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 4, 2000. The Swiss consignee of the Recovered Plasma was sent a second notice dated February 22, 2000 and fax on March 8, 2000. Firm-initiated recall complete. DISTRIBUTION Arizona, Montana, Switzerland. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis B. ________ PRODUCT Licensed, sterile, stable, lyophilized blood factors derived from pooled human plasma; Centeon L.L.C., Kankakee, Illinois 60901; these products were packaged with vials of Sterile Water for Injection for reconstitution, as well as administration sets: a) Mononine Coagulation Factor IX (Human), Monoclonal Antibody Purified; for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease; 1000 Units, NDC #0053-7668-04 b) Monoclate-P Antihemophilic Factor (Human), Factor VII:C Pasteurized Monoclonal Antibody Purified; for treatment of classical hemophilia, also known as Hemophilia A i) 250 Units, NDC #0053-7656-01 ii) 500 Units, NDC #0053-7656-02 iii) 1000 Units, NDC #0053-7656-04 The Mononine and Monoclate-P products were packaged with administration set packets labeled in part: Sterile Administration Components for I.V. Infusion, Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018. The alcohol swabs packaged within this packet were labeled as Sterile Steri Wipe 1 Alcohol Swab, Anajay, Inc., Charlotte, NC 28213. Recall #B-637/638-0. CODE All in-date lots of both products which expire prior to April 2002. MANUFACTURER Aventis Behring L.L.C., Bradley, Illinois. RECALLED BY Aventis Behring L.L.C., King of Prussia, Pennsylvania, by telephone on March 20 and 21, 2000, by fax on March 20-22, 2000, followed by letters. Firm-initiated recall ongoing. SWAB COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY a) 65,700 vials; b) 13,000 250-unit vials, 19,000 500-unit vials, 28,500 1000-unit vials were distributed. REASON The Steri Wipe Alcohol Swabs, packaged with Mononide and Monoclate-P were recalled by Clinipad Corporation due to lack of assurance of sterility. ________ PRODUCT Platelets. Recall #B-654-0. CODE Unit #8083106. MANUFACTURER LifeShare, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by letter dated February 25, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from donors who had taken aspirin within 72 hours of donation. ________ PRODUCT Platelets, Pheresis. Recall #B-655-0. CODE Unit Numbers: 24FH14908, 24FY00091, 24FY00514, 24FY01229, 24FH17914, 24FY01605, 24FY02042, 24FY02233, 24FY02307, 24FH20518, 24FY02540, 24FY02605, 24FY02664, 24FY02793. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated February 14, 2000, March 1 or 7, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky and Indiana. QUANTITY 14 units were distributed. REASON Blood products were collected from a donor taking the drug Piroxicam. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-656/657-0. CODE Unit #13GR08042. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated September 16, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-660-0. CODE Unit Numbers: 0309271 and 0309450. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter dated December 30, 1997. Firm-initiated recall complete. DISTRIBUTION Idaho. QUANTITY 2 units were distributed. REASON Blood products which were positive for the Jkb antigen were transfused to a patient with a Jkb antibody. ________ PRODUCT Red Blood Cells. Recall #B-712-0. CODE Unit Numbers: 4941682, 4955933, 4955940, 4955942. MANUFACTURER Blood Care, Dallas, Texas. RECALLED BY Manufacturer, by telephone on October 1, 1997. Firm-initiated recall complete. DISTRIBUITON Texas. QUANTITY 4 units were distributed. REASON Blood products which were crossmatch incompatible, were distributed for transfusion. ________ PRODUCT Platelet, Pheresis. Recall #B-713-0. CODE Unit #38P45033-1. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on February 20, 1997, and by letter dated March 31, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product corresponding to a split product that was found to be contaminated with Klebsiella pneumonia and implicated in a post-transfusion reaction.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Plasma, Cryoreduced. Recall #B-535-0. CODE Unit Numbers: 29FF32893, 29FF33421, 29FF33428, 29FF33440, 29FF33496, 29FF33498, 29FF33499, 29FF33503, 29FF33505, 29FF33506, 29FF33512, 29KL14281. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated October 15, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 12 units were distributed. REASON Blood products had expiration dates that were extended by four years. ________ PRODUCT Red Blood Cells. Recall #B-653-0. CODE Unit Numbers: 53J60690, 53J60692, 53Y81897, 53Y81898. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on December 28, 1999, and letters dated January 13, 2000, and a corrected letter dated January 27, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland and the District of Columbia. QUANTITY 4 units were distributed. REASON Red Blood Cells either did not meet the hematocrit, or were suspected of not meeting the hematocrit.RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
________ PRODUCT Sterile Custom Surgical & Procedure Kits/Trays packaged by Allegiance Healthcare Corp., McGaw Park, IL, under three divisions, Custom Sterile Division, Medsurg/Isolyser Division and Custom Products/PBDS Division. These kits, containing antiseptic products recalled by Clinipad Corporation, are packed according to the special order requirements of the customer. Recall #Z-604-0. CODE (Note: If necessary a complete list of model information, codes/lot numbers can be obtained from the Chicago District Recall Coordinator). MANUFACTURER Allegiance Healthcare Corporation, Custom Sterile Divis, McGaw Park, Illinois. RECALLED BY Manufacturer, by letter dated April 5, 2000, informing the accounts that the Allegience trays contained Clilipad products subject to recall for lack of assurance of sterility. The letter also included a list of the affected products shipped to the account, as well as a supply of red stickers that stated, "URGENT! Product Correction STOP Remove and Discard any CLINIPAD Antiseptics in This Item", which the accounts were instructed to affix to any of the affected inventory in their possession. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY 341,746 kits/trays were distributed. REASON Class I - Kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria. Class II - Kits/trays contain Clinipad products for which the sterility could not be assured. Recall has been classified as Class I and Class II Devices packaged and distributed by Allegiance Healthcare Medsurg and PBDS Division - Class I. Kits/Trays packaged and distributed by the firm's Custom Sterile Division, which was able to identify the Clinipad products and lots used, for which the sterility could not be assured - Class II. ________ PRODUCT Ash Split Cath II Hemodialysis Catheter containing triCitrasol: a) Model No. ASPC24-2T; b) Model No. ASPC28-2T; c) Model No. ASPC32-2T; d) Model No. ASPC36-2T; e) Model No. ASPC55-2T; f) Model No. TRAY552-2T; g) Model No. TRAY553-2T; h) Model No. TRAY593-2T; i) Model No. TRAY594-2T. Recall #Z-669/677-0. CODE All lots numbers. MANUFACTURER Medical Components, Inc., Harleysville, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 6, 2000, and by letters on April 9 and 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY 7,175 units were distributed. REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA. ________ PRODUCT Medcomp Bio-Flex Catheter (CS100) containing triCitrasol, Model No. BFR-6T. Recall #Z-678-0. CODE All lot numbers. MANUFACTURER Medical Components, Inc., Harleysville, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 6, 2000, and by letters on April 9 and 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY 5 units were distributed. REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA. ________ PRODUCT TriCitrasol (46.7% trisodium citrate), Citra and Medcomp part/catalog #PN6030. Recall #Z-679-0. CODE All lot numbers. MANUFACTURER Cytosol Laboratories, Inc., Braintree, Massachusetts. RECALLED BY Medical Components, Inc., Harleysville, Pennsylvania, by letter s on April 14 and 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 16,950 vials were distributed. REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA. ________ PRODUCT TriCitrasol Anticogulant Sodium Citrate Concentrate 46.7% Trisodium Citrate, 30 mL glass vial, used to keep bloodlines open. Recall #Z-692-0. CODE PN6030 (50/pack) and PN6032 (12/pack). All Lots. MANUFACTURER Cytosol Laboratories, Inc., Braintree, Massachusetts. RECALLED BY Manufacturer, by fax on April 14, 2000. Firm-initiated recall ongoing. See also FDA talk paper T00-16, April 14, 2000. DISTRIBUTION Nationwide and Canada. QUANTITY 420,968 30mL-vials were distributed. REASON TriCitrasol may be inadvertently administrated into patients at full strength (46.7%) rather than being diluted as intended. In addition, the device was distributed without appropriate clearances from FDA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Boehringer Mannheim Cretinine Jaffe Reagent, for the quantitative determination of creatinine in serum, plasma, and urine. Recall #Z-680-0. CODE Catalog #1875647. Lot numbers: 69938801 EXP 07/31/01, 69692201 EXP 01/01, and 69518201 EXP 01/01. MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter (Customer Bulletin #00-066) dated April 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Colorado, Florida, Hawaii, Illinois, Indiana, Michigan, Mississippi, New Jersey, New York, North Carolina, Wisconsin. QUANTITY 127 kits were distributed. REASON Product does not meet the specifications for bilirubin interference. __________ PRODUCT Model Elite/Corium Laser Systems, for use in dermatology, dentistry, ophthalmology, ENT, etc. Recall #Z-683-0. CODE None. MANUFACTURER FISMA, Inc., Salt Lake City, Utah. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on May 10, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 147 units were distributed. REASON If a single component on the light feedback circuit were to fail, the laser would emit full power at any power setting. ________ PRODUCT B-D 1 ml Safety-Lok Insulin Syringe, 29G 1/2 Ultrafine Needle, Reorder No. 329464. Recall #Z-684-0. CODE Lot numbers 0005853 and 0106646. MANUFACTURER Becton Dickinson, BD Medical Systems, Franklin Lakes, New Jersey. RECALLED BY Manufacturer, by telephone on March 2, 2000, followed by letter dated March 9 or 23, 2000. Firm-initiated recall complete. DISTRIBUTION Mississippi, Louisiana, Tennessee, Texas, Pennsylvania, Indiana, Minnesota, Ohio, Michigan. QUANTITY 10,500 units were distributed. REASON Product was marked in ml scale instead of insulin units. ________ PRODUCT Infant and Pediatric Ventilators, intended for neonatal, infant, and pediatric ventilation: a) Model IV-100B/Model IV-200 infant and Pediatric Ventilator; b) Model IV-100B/Model IV-200 SAVI System (Ventilator with Synchronized Assisted Ventilation of infants Module). Recall #Z- 685/686-0. CODE Model IV-100B Series w/serial numbers 13460-14490; Model IV-200 Series w/serial numbers 22209-23030 are subject to this recall.) Affected factory overhauls wherein the firm would have attached a battery bracket include any IV-100B or IV-200 Ventilator that received an overhaul between June 10, 1998 and November 19, 1999. MANUFACTURER Seachrist Industries, Inc., Anaheim, California. RECALLED BY Manufacturer, by Product Advisory letters dated November 23, 1999 and December 21, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,831 units were distributed. REASON The metallic battery brackets can become dislodged from the inside back cover of the ventilator and contact the main circuit board assembly of the ventilator’s operating system.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Roche Reflotron Plus Analyzer, Catalog #747461, a bench top photometric chemistry analyzer for clinical use, which utilizes reagent strips for testing of multiple analytes. Recall #Z-668-0. CODE All serial numbers from 4027788 through 4031233 plus all units serviced since November 1997 and had the lower heating plate replaced. MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indianapolis, by a product removal letter (Customer Bulletin #00-077) dated April 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 5,000 units were distributed. REASON There is a potential for erroneous results due to a loose screw in the lower heating plate, which affects the lower heating unit of the analyzer.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
________ PRODUCT Consolidated Nutrition Stressfighter 6 - for the prevention and treatment of the early stages of shipping fever comples (0xytetracycline). Recall #V-093-0. CODE NH3449. MANUFACTURER Consolidated Nutrition, L.C., New Hampton, Iowa. RECALLED BY Manufacturer, by letters on December 13 and 14, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 82 50-pound bags were distributed. REASON Product is mislabeled - Incorrect drug (neo-terramycin) was used instead of terramycin 100. ________ PRODUCT a) Farmtech Premier Feed Additives Aureomycin 10 chlortetracycline medicated, for use in the manufacture of feeds, in 10-pound bags; b) Farmetech Premier Feed Additives Aureomycin 50 chlortetracycline medicated, packaged in 10-pound bags. Recall #V- 096/097-0. CODE Aureomycin 10 5x10 a) BPX1X29 BPX7X29 EPX5X29 MPX1108 BPX2X29 BPX8X29 EPX6X29 MPX2108 BPX3X29 CP11X38 EPX7X29 MPX3108 BPX4X29 EP10X29 EPX8X29 MPX4108 BPX5X29 EPX1X29 EPX9X29 BPX6X29 EPX4X29 MP15108 Aureomycin 10 50# EP10X29 GPX1X59 MP14108 MPX8108 EPX4X29 GPX5X59 MPX5108 MPX9108 EPX5X29 MP11108 MPX5X18 EPX8X29 MP12108 MPX6108 GP10X59 MP13108 MPX7108 b) APX7X39 EPX1X39 HP10X79 HPX9X79 BPX1X39 EPX2X39 HPX1X19 MPX1X98 BPX2X29 EPX3X39 HPX1X79 MPX2X98 BPX2X39 EPX4X39 HPX2X79 MPX3X98 BPX3X39 EPX5X39 HPX3X79 MPX4X98F BPX5X39 EPX7X39 HPX5X79 MPX5X98 EPX0X39 EPX8X39 HPX6X79 MPX6X98 EP11X39 EPX9X39 HPX7X79 EP12X39 GPX6X79 HPX8X79. MANUFACTURER Farmland Industries, Inc., Eagle Grove, Iowa. RECALLED BY Farmland Industries, Inc., Kansas City, Missouri, by telephone between September 29, 1999 and October 1, 1999, followed by letter dated September 30, 1999. Firm-initiated recall ongoing. DISTRIBUTION Iowa, Missouri, Kansas, Nebraska, South Dakota, Illinois, Oklahoma, Minnesota, Wyoming. QUANTITY a) 1,559 5 10-pound bag bales and 1,050 50-pound bags; b) 2,547 5 10-pound bag bales were distributed. REASON Label for 200 g/ton were repealed by FDA and 10 mg/lb should have appeared on the label. END OF ENFORCEMENT REPORT FOR MAY 24, 2000. BLANK PAGES MAY FOLLOW####
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