June 3, 1998 98-22 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Chester's Flamin' Hot Fries, Corn & Potato Snacks, in 1 and 4 ounce bags. Recall #F-493-8. CODE Sell by dates 14 APR, 21 APR, 28 APR, 05 MAY, 12 MAY, 19 MAY, 26 MAY, 02 JUN and 09 JUN MANUFACTURER Frito-Lay, Inc., Topeka, Kansas; Frito-Lay, Inc., Chamblee, Georgia. RECALLED BY Frito-Lay, Plano, Texas, by hand-held computer/communication devices, on April 7, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 6,232,272 bags were distributed; firm estimated that 1,533,821 bags remained on market at time of recall initiation. REASON Product contains undeclared dairy products. _______________ PRODUCT Pasteurized & Homogenized Liquid Egg Product, packed 18-2.2 pound cartons per case. Recall #F-494-8. CODE MAY 22/98 1148, Use Thru/Lot No. MANUFACTURER Vanderpol Eggs Ltd., Abbotsford, BC Canada. RECALLED BY Golden State Food Corporation, Sumner, Washington (distributor), by telephone beginning on May 6, 1998, followed by visits beginning on May 7, 1998. Firm-initiated recall complete. DISTRIBUTION Alaska, Washington state, Idaho, Montana. QUANTITY 325 cases were distributed. REASON Product was found contaminated with Salmonella C1. _______________ PRODUCT Canned Cod (Codfish) Liver in Oil, net weight 300 g. Recall #F-495-8. CODE All codes. MANUFACTURER Euro-Industry, S.P. Szczecin, Poland. RECALLED BY Kransnyi Oktyabr, Inc., USA, Brooklyn, New York, by letter on April 16, 1998. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts, Maryland, Ohio, Illinois, Georgia, Colorado, Washington state. QUANTITY 2,100 cartons (24 tins per carton) were distributed; firm estimated that little product remained on market at time of recall initiation. REASON Product is a low acid canned food which was manufactured without registration or process filing as required by 21 CFR Part 108. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT a) Amoxicillin for Oral Suspension, USP, 125 mg per 5 mL, 80, 100 and 150 ml when mixed, Rx semisynthetic antibiotic, 125 mg/5 mL, NDC #55953-149-38, -40, -47, also packaged under the Major label, Distributed by Major Pharmaceuticals, Livonia, MI, NDC #0904-2619-04, -07 and Qualitest label, Distributed by Qualitest Pharmaceuticals, Inc. Huntsville, AL, NDC #0603-6500-64, -66 b) Amoxcillin for Oral Suspension, USP, 250 mg per 5 mL, 80, 100 and 150 mL when mixed, 250 mg/5 mL, NDC #55953-130-38, -40, -47, also packaged under the Major label, NDC #0904-2620-04, -07, Rx antibiotic. Recall #D-152/153-8. CODE All lots within expiration date. MANUFACTURER Novopharm Limited, Scarborough, Ontario, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Amount distributed: a) 28,776 - 80-mL, 96,301 - 100-mL, 203,444 - 150-mL bottles; b) 40,474 - 80- mL, 246,535 - 100-mL, 970,350 - 150-mL bottles. REASON Lack of assurance of homogeneity. _______________ PRODUCT Atenolol Tablets; a synthetic beta-selective adrenoreceptor blocking agent for the management of hypertension; packaged in 100 & 1000 tablet bottles: a) 50 mg, NDC #55953-039-40, -80, also packaged under the Major label, NDC #0904-7634-60, -80, Rugby label, Mfd for Rugby Laboratories, Inc., Norcross, Georgia, NDC #0536-3330-01, -10, Qualitest label, NDC #0603-2371-21, -32, Martec label, Mfd for Martec Pharmaceutical, Inc., Kansas City, MO, NDC #52555-531-01, -10 and Mova label, Mfd for Mova Pharmaceutical Corp., Caguas, PR 00725, NDC #55370-122-07 b) 100 mg, NDC #55953-401-40, also packaged under the Rugby label, NDC #0536-3331-01, Qualitest label, NDC #0603-2372-21, Martec label, NDC #52555-534-01, and Moore label, Distributed by Moore Drug Exchange, New Britain, Conn., NDC #0839-7724-06. Recall #D-154/155-8. CODE All lots within expiration date. MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Amount distributed: a) 67,459 100-tablet and 49,858 1000-tablet bottles b) 225,873 100-tablet bottles. REASON Lack of blend uniformity assurance. _______________ UPDATE Recall #D-100/103-8, Propranolol HCL (Inwood Laboratories, Inc., Inwood, New York), which appeared in the April 1, 1998 Enforcement Report has been extended to include 29 additional lot numbers: D-100-8: Propranolol HCl 60 mg Extended Release (ER) Capsules, 100 count bottles, NDC # 0258-3609-01, 16 lots -- 7C003 (9/98), 7C004 (11/98), 7C005 (11/98), 7C017 (11/98), 7C018 (11/98), 7C019 (11/98), 7C021 (11/98), 7C022 (11/98), 7D007 (11/98), 7D008 (11/98), 7D009 (11/98), 7F042 (11/98), 7F043 (11/98), 7F044 (11/98), 7F045 (11/98) & 7F046 (11/98). D-101-8: Propranolol HCl 80 mg ER Capsules, 100 count bottles, NDC # 0258-3610-01. 4 lots - 7C024 (3/99), 7C026 (3/99), 7D014 (3/99) & 7F048 (5/99). D-102-8: Propranolol HCl 120 mg ER Capsules, 100 count bottles, NDC # 0258-3611-01, 6 lots - 7C028 (3/99), 7C029 (3/99), 7F053 (5/99), 7F054 (5/99), 7F056 (8/99) & 7F057 (8/99). D-103-8: Propranolol HCl 160 mg ER capsules, 100 count bottles, NDC # 0258-3612-01, 3 lots - 7C033 (3/99), 7F058 (5/99) & 7F060 (5/99). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT a) OTO-Care (otic), Antipyrine 810 mg/Benzocaine 210 mg, 1/2 fluid ounce bottles, used for the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms susceptible to the action of the antimicrobial, and is also labeled to control itching; b) OTO Care HC (Otic) Chloroxylenol USP 1 mg/Benzocaine 14 mg Hydrocortisone, USP, 10 mg 1/2 fluid ounce bottles, used to treat acute otitis media of various etiologies. Recall #D-147/148-8. CODE Lot numbers: a) F-2465 EXP 6/99; b) F-2459 EXP 6/99. MANUFACTURER Propharma, Inc., Miami, Florida. RECALLED BY Manufacturer, by a) telephone followed by fax on April 3, 1998; b) by telephone and fax on May 4, 1998. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY Approximately 6,760 bottles were distributed. REASON Stability - Accelerated stability testing failures for benzocaine/hydrocortisone in OTO care HC and antipyrine/benzocaine in OTC care. _______________ PRODUCT Neomycin and Polymyxin B Sulfate and Hydrocortisone Otic Solution, USP (Neomycin sulfate, equivalent To 3.5 mg Neomycin base/Polymyxin B Sulfate 10,000 units/Hydrocortisone 10 mg), 10 mL bottles of 30, used for otic use only, under the following labels: Schein Pharmaceutical, Steris Laboratories Inc., Akorn, Carlisle, Erva, Fougera, Geneva, Generics of Puerto Rico, Goldline, IDE, H. L. Moore, Major, Marlop Pharmaceuticals Inc., Mason, Parmed, Robar Inc., Rugby, Teral, Teva, and United Research Laboratories. Recall #D-149-8. CODE 95C960, 95C961, 95D370, 95D371, 95D420, 95D620, 95D950, 95D951, 95D970, 95E040, 95E260, 95E410, 95E790, 95E990, 95F380, 95F570, 95G200, 95G450, 95G830, 95H020, 95H021, 95H640, 95H880, 95H881, 95J070, 95J120, 95L240, 95L820, 96A360, 96A490. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter on March 18, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 2,230,007 bottles were distributed; firm estimated that 16,000 bottles remained on the market at time of recall initiation. REASON Stability - Lack of data at labeled storage conditions. _______________ PRODUCT Piroxicam Capsules, USP; for acute or long-term use in the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis; packaged in bottles of 100, 500 & 1000 capsules: a) 10 mg, NDC #55953-617-40 b) 20 mg, NDC #55953-640-40, -70, -80 also packaged under the Moore label, NDC #0839-7774-06, -16; Major label, NDC #0904-5063-60, -40; and Mova label, NDC #55370-841-07. Recall #D-156/157-8. CODE All lots within expiration date. MANUFACTURER Novopharm, Ltd., Scarborough, Ontario, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Amount distributed: a) 15,390 100-capsule bottles; b) 52,366 100-capsule, 14,892 500-capsule and 5,147 1000-capsule bottles. REASON Lack of blend uniformity assurance. _______________ PRODUCT Various K.W. Botanicals brand OTC products: a) Achillea & Symphytum 16 Salve (Achillea, Symphytum, Calendula, Hypericum, Mahonia, Plantago, Salvia, Prunella...), in 1 fluid ounce glass bottles, OTC product; b) Thyme & Tea Tree 16 Oil (Plantago, Mahonia, Symphytum, Echinacea, Larrea, Calendula, Oils, Vitamin E, Avocado, Thyme, Tea Tree, Bay, Eucalyptus, Rue, Camphor, Clove, Gum Arabic), in 1/8 ounce glass bottles, for external use only; c) Thyme & Tea Tree 17 Oil (Plantago, Mahonia, Symphytum, Echinacea, Larrea, Calendula, Oils; Vitamin E, Avocado, Thyme, Tea Tree, Bay Eucalyptus, Rue, Camphor, Clove, Gum Arabic), in 1/8 ounce glass bottles, for external use only. Recall #D-158/160-8. CODE Lot numbers: a) 4/97; b & c) none. MANUFACTURER K. W. Botanicals, San Anselmo, California. RECALLED BY Manufacturer, by letter on July 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY a) 41 bottles; b) 4 1-dram bottles; c) 40 1-dram bottles. REASON Contamination - One bulk ingredient was detected to contain Lanatosides. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =========== _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1128/1131-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by telephone on November 26, 1997, and/or by letter dated December 12, 1997, and by fax on December 2, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois, Minnesota, Kentucky, Massachusetts, Maryland, Pennsylvania, California. QUANTITY a) 25 units; b) 20 units; c) 5 units; d) 22 units were distributed. REASON Blood products may have been collected in a manner that could compromise the sterility of the products. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1167/1170-8. CODE Unit numbers: 22389-4838, 22389-4832, 22389-2275, 22389-2266 22389-2575, 22390-4631, 22390-5393, 22390-4614, 22390-9566, 22390-9551, 22390-9560, 22390-0565, 22390-7819, 22389-5184, 22390-8386, 22390-7878, 22390-3346. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Manufacturer, by letters between March 20, 1997 and August 1, 1997, and May 9 and 19, 1997, and September 12, 1997. Firm-initiated recall complete. DISTRIBUTION Nevada, New York, Switzerland. QUANTITY a) 3 units; b) 2 units; c) 7 units; d) 10 units were distributed. REASON Blood products were collected from donors whose screening for high risk behavior was inadequately performed. _______________ PRODUCT a) Red Blood Cells; b) Single Donor Plasma; c) Red Blood Cells, for further manufacture; d) Recovered Plasma. Recall #B-1171/1174-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated September 1, 1997, October 1, 1997, November 20, 1997, February 5, 1998, and March 10, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois and California. QUANTITY a) 16 units; b) 3 units; c) 4 units; d) 19 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ========== _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1136/1137-8. CODE Unit #17FZ00520. MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by telephone on February 20, 1998. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who reported a post donation sore throat, were not quarantined, and were distributed after receipt of the information. _______________ PRODUCT Reagent Red Blood Cells, Panocell-10; and Reagent Red Blood Cells, Panocell-10, Ficin Treated. Recall #B-1166-8. CODE Reagent Red Blood Cells, Panocell-10, Lot 04587, and Reagent Red Blood Cells, Panocell-10, Ficin Treated, Lot 04587E. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by letter dated January 26, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 507 kits (Lot #04587) and 187 kits (lot #0487E). REASON Reagent Red Blood Cells, incorrectly identified as f negative on the accompanying master list, Problem: Reagent Red Blood Cells, incorrectly identified as f negative on the accompanying master list. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ============= _______________ PRODUCT National Medical Care brand Venous Hemodialysis Bloodlines. Recall #Z-582-8. CODE Catalog No. 03-7317-5, Lot Nos. R7J001, R7J002 and R7J004. MANUFACTURER Fresenius Medical Care North America, Lexington, Massachusetts. RECALLED BY Fresenius Medical Care North America, Renal Product Technologies, Lexington, Massachusetts, by letter on April 29, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 1,595 cases (24 units per case) were distributed. REASON There is a possibility that a portion of the lots were not processed according to validated sterilization cycle, therefore, compromising the sterility of the bloodlines. _______________ PRODUCT Apnea slow breath and heart rate monitors: a) Assurance 2000 Heart/Respiration Monitor b) Assurance 2000 Hospital Monitor. Recall #Z-583/584-8. CODE Model Number Serial Number 2000WH 7057 A-2000 11935*** *** = 077, 562, 565 through 595, 597 through 621, 624, 627, 629 through 640, 642 through 648, 651, 653, 655, 658 through 691, 696, 701, through 706, 708 through 777, 779 through 819, 821 through 853, 855 through 999 11936*** *** = 000 through 048, 051 through 086. 088 through 116, 118, 119, 121 through 133, 135 through 217, 219 through 221, 223 through 247, 249 through 252, 254 through 290, 292, 294 through 311, 313 through 375, 377 through 381, 384 through 386, 388 through 393, 395 through 418, 420 through 433, 435 through 456, 458 through 483, 485 through 579, 582, 584 through 594, 596, 597, 598,604 through 666, 668, 670 through 681, 683 through 703, 705 through 715, 717 through 731, 733, 734, 735, 737, 738, 740, 741, 742 11938*** *** = 830, 832, 865, 870, 871, 874 33495 A2000H 8890 through 8901, 8906, 8907, 8908, 8910 through 8913. MANUFACTURER Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter dated May 13, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 1,143 devices were distributed. REASON Contaminated circuit boards could cause a product malfunction. The devices could fail to alarm, when an alarm is appropriate to warn of apnea or abnormal heart rate. _______________ PRODUCT Bipolar Rx Pacing Leads, intended for use with pulse generators for long-term cardiac pacing. Recall Z-585-8. CODE All leads manufactured since 1983. MANUFACTURER Aulzer Oscor, Inc. (Formerly Oscor Medical Corporation), Palm Harbor, Florida. RECALLED BY Manufacturer, by letter mailed beginning April 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 21,000 leads were distributed. REASON The polyurethane insulation of the device is cracking resulting in higher than normal failure rates. _______________ PRODUCT R.S.V. Collection Kit, Nasal Washing Kit and Would Care Tray: a) Centurion Hospital Products brand Latex Free Nasal Washing Kit, Reorder #RSV1525 b) Centurion Hospital Products brand R.S.V. Collection Kit, Reorder #S2070. c) Centurion Hospital Products brand Wound Care Tray, Reorder # WT1180. Recall #B-588/590-8. CODE Lot numbers: a) S11037, S01198 and S03098 b) S01058; c) 12166, 12026, 04287, 06097, 06167, 06307, 09157, 09297, 10137, M11037, M11247, M12157, and M02028. MANUFACTURER Kendall Healthcare Products Company, Mansfield, Massachusetts (component). RECALLED BY Tri-State Hospital Supply Corporation, Howell, Michigan. DISTRIBUTION California, Georgia, Iowa, Minnesota, Nebraska, Texas, Virginia. QUANTITY Amount Dist. Estimated in Marketplace a) 900 less than 200 b) 100 0 c) 19,140 less than 4,020 REASON contain sodium chloride solution which is labeled as sterile which is contaminated with Ralstonia pickettii (formerly referred to as Pseudomonas pickettii), an opportunistic pathogen. _______________ PRODUCT Companion CR50 Conserving Oxygen Regulators, designed to be used with high-pressure oxygen cylinders to conserve oxygen and is both a regular and conserving device: a)Companion CR50 Conserving Oxygen Regulators, Part 134220-01, b) Companion R50 Conserving Oxygen Regulators, Part 134221-01, CODE Lot Numbers: a) 741A, 745A, 751A, 803A; b) 745A. MANUFACTURER Nellcor Puritan Bennett, Inc., Lenexa, Kansas. RECALLED BY Manufacturer, by letter dated April 14, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Japan. QUANTITY 1,025 units were distributed. REASON The units have a potential for a no flow condition during operation caused by a gasket associated with the pressure relief valve of the regulator. RECALLS AND FIELD CORRECTIONS: DEVICES CLASS III="===========" _______________ PRODUCT B.E.C. Growth Chek Microbial Suspension of Bacillus, used for quality control testing of culture media per USP Growth Promotion testing and Bacteriostasis/Fungistasis Testing methods. Recall #Z-561-8. CODE Lot #012798 EXP 7/27/98. MANUFACTURER Biological & Environmental Control Laboratories, Inc., doing business as B.E.C. Laboratories, Inc., Toledo, Ohio. RECALLED BY Manufacturer, by letter on April 30, 1998. Firm-initiated recall ongoing. DISTRIBUTION New York, Illinois, Nebraska, New Mexico, Rhode Island, Indiana, Pennsylvania. QUANTITY 18 vials were distributed. REASON The population of bacterial suspension has dropped to less than the labeled population, resulting in failure to meet labeled shelf life. _______________ PRODUCT Revolution Flowable Light Cure Dental Composite, used for permanent tooth fillings. Recall #Z-580-8. CODE The product part numbers are: 28289, 28290, 28660, 28793, 450100, 450102, 450104, 450139. Lot numbers within these part numbers: 709170, 709680, 709789, 710036, 710195, 710372, 710387, 710528, 710577, 710672, 711059, 711085, 711182, 711256, 711303, 711329, 711330, 711339, 711445, 712072, 712083, 712565, 801254, 801405, 803071, 803156, 803366. MANUFACTURER Scientific Pharmaceuticals, Inc., Pomona, California. RECALLED BY Kerr Corporation, subsidiary of Sybron Dental Specialties, Inc., Orange, California, by letter on April 1, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 62,254 syringes were distributed. REASON The resin does not set completely after curing. _______________ PRODUCT Polymyxin B Sulfate, USP, Catalog #0319, received in 135 bulk bottles and is repackaged and distributed under the Amresco label. Firm believes that this product is used as an ingredient for making tissue culture media and biological growth media, or as an ointment placed on a bandage, or as a semen extender. Recall #Z-581-8. CODE Lot #1987A13 EXP 12/31/01. MANUFACTURER Pfizer, Inc, Groton, Connecticut (responsible firm). RECALLED BY Amresco, Inc., Solon, Ohio (repacker), by letter on April 29, 1997. Firm-initiated recall complete. DISTRIBUTION Maine, Massachusetts, Pennsylvania, Arizona, California, Missouri, Ohio, Hong Kong, Shang-Hi, Japan. QUANTITY 36 bottles were distributed. REASON The label has an incorrect potency value. _______________ PRODUCT Centurion Hospital Products brand Pelvic Exam Tray, Reorder #PE2255. Recall #Z-591-8. CODE Lot numbers: S05197, S07077, S08257, S09157, S10207, S02028, S03098. MANUFACTURER Kendall Healthcare Products Company, Mansfield, Massachusetts (component). RECALLED BY Tri-State Hospital Supply Corporation, Howell, Michigan, by telephone or fax on April 21, 1998, and by letter dated April 21, 1998. Firm-initiated recall ongoing. DISTRIBUTION California, Georgia, Iowa, Minnesota, Nebraska, Texas, Virginia. QUANTITY 4,840 units were distributed; firm estimated that less than 600 units remain on the market. REASON Device contains sodium chloride solution which is labeled as sterile which is contaminated with Ralstonia Pickettii (formerly referred to as Pseudomonas pickettii), an opportunistic pathogen. _______________ PRODUCT MLA Electra Automated Coagulation Testing Instruments, used to provide data on blood clotting and factor assays: a) Model E900C (Part No. 1095C), b) Model E1000C (Part No. 1096C). Recall #Z-597/598-8. CODE Serial Numbers: a) 3645 thru 3675; b) 3524-2010, 3523-2011, R001-R001, R004-R004 through R040-R040. MANUFACTURER Medical Laboratory Automation (MLA), Inc., Pleasantville, New York. RECALLED BY Manufacturer, by letter on April 23, 1998. Firm-initiated field correction ongoing. DISTRIBUTION New York, New Jersey, Maryland, Virginia, West Virginia, Tennessee, Florida, Illinois, Michigan, Texas, Oklahoma, Arizona, California. QUANTITY a) 31 units; b) 38 units were distributed. REASON The video boards are not compatible with the central processing unit. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS CLASS II="==" _______________ PRODUCT ChlorhexiDerm Scrub 2% Chlorhexidine, antiseptic antimicrobial surgical scrub. Recall #V-023-8. CODE Lot Numbers: 7347 and 7347A. MANUFACTURER DVM Pharmaceuticals, Inc., Miami, Florida. RECALLED BY Manufacturer, by letter dated April 21, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,160 gallons were distributed; firm estimated little product remained on market at time of recall initiation. REASON Product analyzed and tested positive for Serratia marcescens and Pseudomonas aeruginosa. _______________ PRODUCT Radix Labs Milk Fever K Sterile, nonpyrogenic (for the treatment of milk fever in cattle), in 500 ml bottles. Recall #V-024-8. CODE Lot numbers R6P010 EXP 11/98. MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin. RECALLED BY Manufacturer, by letter dated May 11, 1998. Firm-initiated recall ongoing. DISTRIBUTION Minnesota, Wisconsin, Illinois and Iowa QUANTITY 1,850 500-ml bottles were distributed. REASON Precipitate found in the injectable product at 18 month check (product has 2 year expiration dating). RECALLS AND FIELD CORRECTIONS VETERINARY PRODUCTS: CLASS III _______________ PRODUCT Nutrena Chick Starter-Grower with Amprolium and Ethopabate, type C medicated feed (for coccidiosis prevention). Recall #V-025-8. CODE Lot # F8089. MANUFACTURER Cargill Feed Division, Nutrena Feeds Division, Flora, Illinois. RECALLED BY Manufacturer, by telephone on April 15, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 225 bags were distributed. REASON The medicated feed was manufactured with the wrong Type A medicated article. The Ethopabate active drug ingredient was left out at manufacture. END OF ENFORCEMENT REPORT FOR JUNE 3, 1998. ####