FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


June 06, 2001                                                   01-22



RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________ PRODUCT: Red Blood Cells. Recall # B-1078-1. CODES: Unit E48329. MANUFACTURER: Central California Blood Center,Fresno, CA. RECALLED BY: Manufacturer, by letter dated January 7, 1999. Firm-initiated recall complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Blood product, collected from a donor with a history of having tested positive for Hepatitis B, was distributed. _______ PRODUCT: Platelets, Pheresis, Leukroduced. Recall # B-1256-1. CODES: Unit 9044645 (bag 2). MANUFACTURER: Community Blood Center of Greater Kansas, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on December 15, 1998. Firm-initiated recall complete. DISTRIBUTION: MO. QUANTITY: 1 unit. REASON: Blood product, which was labeled as leukoreduced but did meet the standard for a leukroreduced product, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1259-1. b) Platelets. Recall # B-1260-1. c) Recovered Plasma. Recall # B-1261-1. CODE: a), b) and c) Unit Y39004. MANUFACTURER: Aurora Area Blood Bank, Aurora, IL. RECALLED BY: Manufacturer, by letters dated February 27, 2001, or by facsimile dated March 1, 2001. Firm-initiated recall is complete. DISTRIBUTION: IL and Switzerland. QUANTITY: 3 units. REASON: Blood products, collected from a donor who was at increased risk for new variant Creutzfeld-Jakob Disease (nvCJD), was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1286-1. b) Recovered Plasma. Recall # B-1287-1. CODE: a) and b) Unit 53J64493. MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. A questionable Plasma inquiry was forwarded to the Swiss consignee of the Recovered Plasma on December 26, 2000. Firm-inititated recall complete. RECALLED BY: Manufacturer, by letter dated December 27, 2000. Firm-initiated recall complete. DISTRIBUTION: MD and Switzerland. QUANTITY: 2 units. REASON: Blood products, collected from a donor who took the drug Proscar, were distributed. ________ PRODUCT: Pulmonary Patch Graft, Human Tissue for Transplant. Recall # B-1292-1. CODES: ID 98-0271HV-02, 1 allografts. MANUFACTURER: LifeNet, Virginia Beach, VA. RECALLED BY: Manufacturer, by telephone on March 28, 2001, and by letter dated April 9, 2001. Firm-initiated recall is complete. DISTRIBUTION: MO. QUANTITY: 1 unit. REASON: Tissue for transplant, which was collected from a donor who had not been properly evaluated, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1294-1. b) Recovered Plasma. Recall # B-1295-1. CODE: a) and b) Unit 49GV02909. MANUFACTURER: American Red Cross, Farmers Branch, TX. RECALLED BY: American National Red Cross, Southwest Region, Tulsa, OK, by letter dated March 2, 2000. Firm-initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Blood products, which tested negative for anti-HCV, but were collected from a donor who provided post donation information regarding having previously tested repeatedly reactive for anti-HCV, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1296-1. b) Fresh Frozen Plasma. Recall # B-1297-1. CODES: a) and b) Unit 55W60869. MANUFACTURER: American National Red Cross, Greater Ozarks-Arkansas, Little Rock, AR. RECALLED BY: Manufacturer, by letters dated either September 25, 2000 or September 27, 2000. Firm-initiated recall is complete. DISTRIBUTION: AR. QUANTITY: 2 units. REASON: Blood products, which tested negative for anti-HCV, but were collected from a donor who provided post donation information regarding having previously tested repeatedly reactive for Hepatitis C, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1298-1; b) Platelets. Recall # B-1299-1; c) Fresh Frozen Plasma. Recall # B-1300-1. CODE: a), b) and c) Unit 1648236. MANUFACTURER: Central Kentucky Blood Center, Lexington, KY. RECALLED BY: Manufacturer, by letters dated March 22, 2001. Firm initiated recall complete. DISTRIBUTION: KY. QUANTITY: 3 units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. _______ PRODUCT: Cornea. Recall #B-1302-1. CODES: Id. # 00-569 (OD). MANUFACTURER: Lions Eye Bank of Central Texas, St. David’s Medical Center, Austin, TX. RECALLED BY: Manfacturer, by letter dated January 25, 2001. Firm-initiated recall complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Cornea, that were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), was distributed. ________ PRODUCT: a) Red Blood Cells Leukoreduced. Recall # B-1305-1; b) Recovered Plasma. Recall # B-1306-1. CODE: a) and b) Unit 21GN06544. MANUFACTURER: American Red Cross,Pacific Northwest Regional Blood Services, Portland, OR. RECALLED BY: Manufacturer, by letter dated September 14, 2000. Firm-initiated recall is complete. DISTRIBUTION: WA. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1307-1; b) Recovered Plasma. Recall # B-1308-1. CODES: a) and b) Units 20LZ03903, 20LY10440, 20LY23266. MANUFACTURER: American Red Cross, Lewis and Clark Region, Boise, ID. RECALLED BY: Manufacturer, by letters dated November 1, 2000. A questionable Plasma Inquiry was forwarded to the Swiss consignee of the recovered Plasma on November 7, 2000. Firm initiated recall is complete. DISTRIBUTION: CA, WA, OR and Switzerland. QUANTITY: 6 units. REASON: Blood products, which tested negative for all required viral marker tests, but were collected from a donor who had previously tested positive for Hepatitis B, due to mononucleosis, were distributed. ________ PRODUCT: a) Red Blood Cells, Leukoreduced. Recall # B-1309-1. b) Recovered Plasma. Recall # B-1310-1. CODES: a) and b) Units 21Y62308, 21KK32558. MANUFACTURER: American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR. RECALLED BY: Manufacturer, by letters dated January 2, 2001 and January 4, 2001. Firm- initiated recall is complete. DISTRIBUTION: OR. QUANTITY: 4 units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a) Red Blood Cells Leukoreduced. Recall # B-1311-1. b) Fresh Frozen Plasma. Recall # B-1312-1. CODES: a) and b) Unit 21KF18098. MANUFACTURER: American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR. RECALLED BY: Manufacturer, by telephone on December 27, 2000, and by letters dated January 4, 2001. Firm-initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1317-1. CODES: Unit 53GQ83410. MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by letter dated February 6, 2001. Firm-initiated recall is complete. DISTRIBUTION: MD. QUANTITY: 1 unit. REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1318-1. CODES: Unit 36261-0611. MANUFACTURER: United Blood Services, Ventura, CA. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, notified by telephone on March 15, 2001, and by letter dated April 13, 2001. Firm-initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1338-1. b) Platelets, Irradiated. Recall # B-1339-1. MANUFACTURER: a) and b) Unit number 0123015. RECALLED BY: Manufacturer, notified by letter dated August 16, 1999. Firm- initiated recall is complete. DISTRIBUTION: MI. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall # B-1343-1. CODES: Unit number 29FN33891. MANUFACTURER: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by telephone on December 22, 2000, and by letter dated December 27, 2000. Firm-initiated recall is complete. DISTRIBUTION: NC. QUANTITY: 1 unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall # B-1344-1. CODES: Unit number 29FK36084. MANUFACTURER: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by letter dated January 10, 2001. Firm-initiated recall is complete. DISTRIBUTION: VA. QUANTITY: 1 unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1345-1. b) Red Blood Cells, Leukocytes Reduced. Recall # B-1346-1. c) Platelets. Recall # B-1347-1. CODES: a) Unit number 29FV42365; b) Unit numbers 29FK37126 and 29KX06472; c) Unit number 29FV42365. MANUFACTURER: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer by telephone on November 4, 2000, and by letter dated November 7, 2000. Firm-initiated recall is complete. DISTRIBUTION: MD, VA and NC. QUANTITY: 4 units. REASON: Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-1348-1. CODES: Unit number 53GF33173. MANUFACTURER: American Red Cross Blood Services, Gaithersburg, MD. RECALLED BY: The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated November 7, 2000. Firm- initiated recall is complete. DISTRIBUTION: MD QUANTITY: 1 unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: a) Red Blood Cells. Recall # B-1349-1; b) Platelets. Recall # B-1350-1; c) Fresh Frozen Plasma. Recall # B-1351-1. CODES: a) Unit numbers M32492, M34611, M36372, K76657, KH16529, KN01717, KN05379, KH39776, and KH45623; b) Unit numbers M32492, M34611, M36372, KH13222, KH16529, KN01717, KN05379, KH39776, and KH45623; c) Unit numbers M34611, M36372, KH13222, KN01717, KH39776, and KH45623. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: The recalling firm by letter dated October 31, 2000. Firm-initiated recall is complete. DISTRIBUTION: VA. QUANTITY: 24 units. REASON: Blood products, that tested negative for antibody to hepatitis B core antigen (anti-HBc), but were collected from a donor that previously tested repeatedly reactive for anti-HBc on more than one occasion, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1352-1; b) Platelets. Recall # B-1353-1; c) Recovered Plasma. Recall # B-1354-1. CODES: a) unit numbers M32750 and L03625; b) Unit number M32750; c) Unit numbers M32750 and L03625. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by letters dated January 31, 2001, and February 21, 2001. Firm- initiated recall is complete. DISTRIBUTION: VA and Switzerland. QUANTITY: 5 units. REASON: Blood products, collected from an unsuitable donor due to an accidental needlestick during the previous twelve months, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1363-1. CODES: Unit number 2274777. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by telephone on September 30, 2000, and by letter dated October 3, 2000. Firm-initiated recall is complete. DISTRIBUTION: WA. QUANTITY: 1 unit. REASON: Blood product was distributed with labeling that incorrectly indicated that the unit had been irradiated and leukoreduced. ________ PRODUCT: Platelets Pheresis, Leukocytes Reduced. Recall # B-1364-1. CODES: Unit numbers 9007187 (split product), 9008466, 9008503 (split product), 9008470, and 9008465. MANUFACTURER: Carolina-Georgia Blood Center, Inc., Greenville, SC. RECALLED BY: Manufacturer, by letter dated March 9, 2000. Firm initiated recall is ongoing. DISTRIBUTION: SC. QUANTITY: 7 units. REASON: Blood products that were leukoreduced and failed quality control tested for white blood cell count were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT: Source Plasma. Recall # B-1150-1. CODES: Unit 7030016615. MANUFACTURER: NABI BioMedical Center, San Antonio, TX. RECALLED BY: NABI, Boca Raton, FL, by fax transmission dated January 20, 2000. Firm- initiated recall is complete. DISTRIBUTION: North California. QUANTITY: 1 unit. REASON: Blood product, collected from a donor with an elevated temperature, was distributed. ________ PRODUCT: Platelets. Recall #B-1173-1. CODES: Unit 7440357. MANUFACTURER: Carter BloodCare, Bedford, TX. RECALLED BY: Manufacturer, by letter dated August 24, 2000. Firm-initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood product, prepared from a Whole Blood unit that had an extended collection time, was distributed. _______ PRODUCT: Red Blood Cells, Leukoreduced. Recall # B-1186-1. CODES: Unit 18FJ40230. MANUFACTURER: American Red Cross Blood Services, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by telephone and letter on February 7, 2001. Firm-initiated recall is complete. DISTRIBUTION: MI. QUANTITY: 1 unit. REASON: A unit of Red Blood Cells, that was leukoreduced by filtration greater than five days past the time of collection, was distributed. _________ PRODUCT: Allergenic Extract Guinea Pig Epithelia. Recall # B-1217-1. CODES: Lot #A009151A. MANUFACTURER: Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY: Manufacturer, by fax on March 6, 2001 or March 7, 2001. Firm- initiated recall is complete. DISTRIBUTION: OH and MI. QUANTITY: 2 vials. REASON: Allergenic Extract was labeled with an extended expiration date. _________ PRODUCT: Fresh Frozen Plasma. Recall # B-1253-1. CODES: Unit 33GM06451. MANUFACTURER: American Red Cross, Connecticut Region, Farmington, CT. RECALLED BY: Manufacturer, by telephone on January 11, 2001, and by letter dated January 15, 2001. Firm-initiated recall is complete. DISTRIBUTION: CT. QUANTITY: 1 unit. REASON: Prepared from a potentially traumatic collection in that a hematoma had occurred at the time of donation. _________ PRODUCT: Red Blood Cells. Recall # B-1254-1. CODES: Unit 55L18415. MANUFACTURER: American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR. RECALLED BY: Manufacturer, by facsimile on June 20, 2000, and by letter dated July 27, 2000. Firm initiated recall is complete. DISTRIBUTION: AR. QUANTITY: 1 unit. REASON: Blood product, collected in an expired blood collection bag was distributed. _________ PRODUCT: Platelets, Pheresis. Recall # B-1255-1. CODES: Unit 9044123 (bag 1). MANUFACTURER: Community Blood Center of Greater Kansas, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on November 10, 1998. Firm-initiated recall is complete. DISTRIBUTION: MO. QUANTITY: 1 unit. REASON: A Platelets, Pheresis unit, that was not stored under continuous agitation, was distributed. _________ PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall # B-1262-1. CODES: Unit 22405-3992 MANUFACTURER: Blood Systems Incorporated (United Blood Services), Las Vegas, NV. RECALLED BY: Blood Systems, Incorporated, Scottsdale, AZ, notified the Arizona consignee by telephone on January 24, 1999. Firm-initiated recall is complete. DISTRIBUTION: AZ. QUANTITY: 1 unit. REASON: Unlicensed blood product was distributed in interstate commerce. _________ PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall # B-1263-1. CODES: Unit F35455. MANUFACTURER: Walter L. Shepeard Community Blood Center, Augusta, GA. RECALLED BY: Manufacturer, by telephone on November 16, 1998. Firm-initiated recall is complete. DISTRIBUTION: SC. QUANTITY: 1 unit. REASON: Unlicensed blood product was distributed in interstate commerce. _________ PRODUCT: Platelets Pheresis, Leukocyte Reduced. Recall # B-1280-1. CODES: Unit P79217. MANUFACTURER: American Red Cross Blood Services, Heart of America Region, Peoria, IL. RECALLED BY: Manufacturer, by telephone on November 17, 2000. Firm-initiated recall is complete. DISTRIBUTION: IL. QUANTITY: 1 unit. REASON: Leukoreduced product, that had a WBC count performed using a sample that exceeded time frame requirements for analysis, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1288-1; b) Platelets. Recall # B-1289-1; c) Plasma. Recall # B-1290-1; d) Source Leukocytes. Recall # B-1291-1. CODE: a) Units 53G19937, 53J13228, 53FR41846, 53R08719, 53T10977; b) Units 53G19937, 53FR41846, 53T10977; c) Units 53J13228, 53T10977; d) Unit 53G19937. MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by letters dated January 10. 2001. Firm-initiated recall is complete. DISTRIBUTION: MD, NJ. QUANTITY: 11 units. REASON: Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1293-1. CODES: Unit 22413-3427. MANUFACTURER: Blood Services, Inc., Las Vegas, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on March 8, 2000. Firm initiated recall is complete. DISTRIBUTION: NV. QUANTITY: 1 unit. REASON: Blood product, that was not quarantined after receiving information concerning a post donation illness. ________ PRODUCT: Source Plasma. Recall # B-1304-1. CODES: Unit 7030091384. MANUFACTURER: NABI BioMedical Center, San Antonio, TX. RECALLED BY: Manufacturer, by fax transmission dated June 18, 1999. Firm-initiated recall is complete. DISTRIBUTION: United Kingdom. QUANTITY: 1 unit. REASON: Source Plasma, collected from a donor who did not complete the donor medical history questions, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ UPDATE: Recall # Z-533/534-1, which appeared in the May 16,2001, Enforcement Report has been updated as follows: ________ PRODUCT: Z-592-1 - King Systems brand Jackson-Rees Modification Breathing Ciruits; Z-593-1 - King Systems brand Mapleson D Breathing Circuit; Z-594-1 - Ped F2 Pediatric Anesthesia Breathing Circuit; Z-595-1 - Norman Elbow, individually packed [VETERINARY DEVICE]: Anesco brand Mapleson C Breathing Circuits;

RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II

________ PRODUCT & CODES: Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in bulk, intended for both ruminant and non-ruminant animals. The products are as follows: Recall # V-195-1 through V-350-1. RUMINANT FEED PRODUCTS: RECALL NO. PRODUCT NO. PRODUCT NAME V-195-1 40150 B. 30% Calf Pellet V-196-1 40250 B. 16% Calf Pellet V-197-1 40350 B. 16% Calf Ration V-198-1 40450 B. 18% Calf Starter V-199-1 40600 B. 38% Dairy Pellet V-200-1 40650 B. 38% Dairy Pellet V-201-1 40750 B. 16% Dairy Feed V-202-1 40950 B. 40% Beef Pellet V-203-1 41150 B. 18% Lamb Starter Pellet V-204-1 41250 B. 39% Lamb Conc. Pellet V-205-1 41350 B. 14% Lamb & Beef Pellet V-206-1 41450 B. 16% Goat Feed V-207-1 42150 B. 32% Expectation Pellet V-208-1 42250 B. Llama & Alpaca Pellet V-209-1 42350 B. 32% Calf Grower Pellet V-210-1 42650 B. Llama & Alpaca Crums V-211-1 42750 B. 38% Hay Booster 2 V-212-1 42850 B. 25% Pasture Booster V-213-1 43100 B. 16% Grower/Dev Pellet V-214-1 43150 B. 16% Grower/Dev Pellet V-215-1 43700 WH 32% Calf Gro Pellet V-216-1 43750 WH 32% Calf Gro Pellet V-217-1 43850 B. 38% Dairy Mix V-218-1 44250 B. 17% Doe Pellet V-219-1 44350 B. 21% Buck Pellet V-220-1 44450 Legends Ranch Pellet V-221-1 44500 Legends 17% Breeder Pellet V-222-1 1652 B. Vitamin E-20 V-223-1 1614 B. Vitamin A-30 V-224-1 44550 Legends 17% Breeder Pellet V-225-1 44650 Legends 13.5% Rut Pellet V-226-1 44750 Deer Starter (J) V-227-1 44940 Llama Premix (J) FSC V-228-1 45150 Empire 25% Calf Pellet V-229-1 45450 Berry Llama Pellet V-230-1 45950 50% Beef Conc. (Meal) V-231-1 46250 B. 12% Sweet Livestock V-232-1 46350 B. 1440 Bovatec Pellet V-233-1 46400 Liberty 38% Dairy Pellet V-234-1 46450 Liberty 38% Dairy Pellet V-235-1 47150 B. 14% Gold-n-Grower V-236-1 47250 B. 12% Gold-n-Conditioner V-237-1 47450 B. 18% Gold-n-Lamb V-238-1 47800 Homeworth Dairy Pellet V-239-1 47850 Homeworth Dairy Pellet V-240-1 47900 B. 36% Hi Fat Dairy Pellet V-241-1 47950 B. 36% Hi Fat Dairy Pellet V-242-1 48550 B. 16% Calf Pellet CA V-243-1 49200 Mastead Dairy Base V-244-1 49300 KLEJKA Dairy Base V-245-1 49650 Deer Premix (J) HFB V-246-1 49750 39% Lamb Premix (J) HFB V-247-1 49850 Lamb Starter Premix (J) HFB V-248-1 120850 Brood Cow Deluxe Mineral V-249-1 152850 B. A-D-E Mix NON-RUMINANT FEED PRODUCTS: V-250-1 10150 B. Miracle Starter V-251-1 10350 B. 21% Broiler Starter V-252-1 10450 B. Pullet Grower & Developer V-253-1 10550 B. 18% Layer Breeder Pellets V-254-1 10750 B. 20% Gold Std. Laying Crum V-255-1 10950 B. 17% Complete Laying Crums V-256-1 11050 B. 16% Prosperity Layer Crums V-257-1 11100 B. 40% Poultry Concentrate V-258-1 11150 B. 40% Poultry Concentrate V-259-1 11250 B. 28% Turkey Starter Crums V-260-1 11350 20% Gig "4" Pellets V-261-1 11450 B. 16% Prosperity Layer Pellets V-262-1 11550 18% Game Bird Breeder Pellets V-263-1 11650 B. 19% Ratite Grower Diet V-264-1 11750 B. 23% Ratite Breeder Diet V-265-1 12100 B. 40% Poultry Concentrate Crums V-266-1 12550 B. 32% Base Poultry Mix V-267-1 13250 B. 28% Turkey Starter V-268-1 13450 B. 20% Poultry Grower V-269-1 14325 B. Game Bird Mix - Coarse V-270-1 20150 B. 18% Pig Starter Pellets V-271-1 20250 B. 16% Pig Grower Pellets V-272-1 20450 B. 14% Porkmaker 100 Pellets V-273-1 20550 B. 40% Gro 'Em Lean V-274-1 21850 B. 27% Hi-Fat Swine Base V-275-1 23000 Mt. Hope Hevy Hog V-276-1 30050 12% Pleasure Horse - Sweet V-277-1 30150 Alfa + Performer 10 Sweet V-278-1 30250 14% Grass + Perf Sweet V-279-1 30450 12% Wrangler - Complete V-280-1 30550 B. 12% Pleasure Horse Pellets V-281-1 30650 B. 32% Gro' N Win Pellets V-282-1 30750 12% Wrangler Cubes V-283-1 30950 18% Foal Starter V-284-1 31050 B. 14% Alfa + Dev Pellets V-285-1 31150 B. Alfa + Performer 10 Pel V-286-1 31200 Grass +Performer 14 Pel V-287-1 31250 Grass +Performer 14 Pel V-288-1 31350 12% Mustang V-289-1 31450 Endurance - 101 Extruded V-290-1 31550 B. Equine Energy - UK V-291-1 31650 B. 16% Grass + Dev Pellets V-292-1 31750 16% Grass + Dev Cubes V-293-1 31850 16% Grass + Dev Sweet V-294-1 31950 B. 11% Alfa Gro 'N Win Pel V-295-1 32050 B. Sho' Win Pellets V-296-1 32250 B. Senior Formula V-297-1 32350 Oscar Horse Mix V-298-1 32450 B. Ultimate Finish V-299-1 32550 Crossfire Horse Feed V-300-1 32650 B. Equine 16% Growth V-301-1 32750 B. Reduced Energy Formula V-302-1 32850 B. Training Formula V-303-1 32950 B. Cadence Formula V-304-1 33150 B. Track 12 Horse Feed V-305-1 33350 Spears 16% GR + Dev Cubes V-306-1 33400 B. 14% Supreme Horse Pellets V-307-1 33450 B. 14% Supreme Horse Pellets V-308-1 33650 B. Race'N Win V-309-1 33750 B. 14% Prominent Horse Feed V-310-1 33850 B. Unbeetable Horse Feed V-311-1 34750 Cargill Senior Horse V-312-1 34850 Cargill Vitality Gold V-313-1 35150 Chagrin 12% Sweet Fd V-314-1 35250 Smith Pure Pleasure V-315-1 35750 Roundup 10% Horse Pellets V-316-1 35850 12% Summerglo Horse V-317-1 36255 B. Grass +Min&VitBase - Mexico V-318-1 36850 Miller's 12% Horse Feed V-319-1 37155 B. Gro'Win Base Mix - Mexico V-320-1 38000 B. 32% Premium Mixer Pellets V-321-1 38050 B. 32% Premium Mixer Pellets V-322-1 38100 36% Maintenance Mixer Pellets V-323-1 38150 36% Maintenance Mixer Pellets V-324-1 50150 Terramycin Crumbles V-325-1 60105 16% Rabbit Pellets V-326-1 60125 16% Rabbit Pellets V-327-1 60150 B. 16% Rabbit Pellets V-328-1 60205 18% Rabbit Developer V-329-1 60250 B. 18% Rabbit Developer V-330-1 60450 B. 16% Rabbit Maintenance V-331-1 90150 B. Buckeye Scratch V-332-1 90225 Gold Standard Scratch V-333-1 90250 Gold Standard Scratch V-334-1 90350 Intermediate Scratch V-335-1 90450 B. Chick Grains V-336-1 90525 B. Shelled Corn V-337-1 90550 B. Shelled Corn V-338-1 90650 B. Cracked Corn V-339-1 90825 B. Fine Cracked Corn V-340-1 90850 B. Fine Cracked Corn V-341-1 91000 Steam Flaked Corn V-342-1 91050 Steam Flaked Corn V-343-1 91750 Oats - HP Crimped V-344-1 91850 B. HP Sweet Crimped Oats V-345-1 95550 Land O' Lakes Shelled Corn V-346-1 95650 Land O' Cracked Corn V-347-1 95850 Land O' Lakes Chick Crack V-348-1 100850 B. Alfalfa Pellets V-349-1 101850 Cooked Full Fat Soybean V-350-1 122200 Magnatone M-4-B Pels Bulk MANUFACTURER: Buckeye Feed Mills, Dalton, Ohio. RECALLED BY: Manufacturer visited local customers on April 17, 2001. On April 18 and 19, 2001, manufacturer mailed and faxed recall notices. Firm initiated recall is ongoing. DISTRIBUTION: Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC, OH, OR, PA, RI, TN, VA, WV, and WI. QUANTITY: 2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed products. REASON: The animal feed products may contain protein derived from mammalian tissues.

RECALLS AND FIELD CORRECTIONS: VET MED -- CLASS III

________ PRODUCT: MaxiLean 48/16 50627CGP (Type A Category II Medicated Article). The product consists of 260 grams per ton of Monensin and 120 grams of Tylosin 40. Recall # V-194-1. CODES: CH22300. MANUFACTURER: Consolidated Nutrition, LC, Camp Hill, Pennsylvania. RECALLED BY: Consolidated Nutrition, LC, Omaha, Nebraska., by telephone on August 11, 2000. Firm-initiated recall is complete. DISTRIBUTION: PA. QUANTITY: 9,815 pound bulk shipment. REASON: Wrong drug had been used.
END OF ENFORCEMENT REPORT FOR June 6, 2001.
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