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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced Irradiated FZ84753; FZ67148 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Tri-Counties Blood Bank dba UBS- Central Coast
Biologics Red Blood Cells Leukocytes Reduced 42FT70229, 42FT70233, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 42FT70246, 42FT70255, 42FT70306, 42FX56668, 42FX56674, 42FX56684, 42FX56690 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 42FT70229, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690 Class III Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Source Plasma 0210062043 0210062481 0210063444 0210063852 0210064554 0210064603 0210065081 0210065608 0210065837 0210066266 0210066480 0210067362 0210067724 0210067973 0210068300 0210068633 0210068854 0210069332 0210069618 0210070022 0210070334 0210070650 0210070994 0210071289 Class III Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed. Biomat USA, Inc.
Biologics Fresh Frozen Plasma 5304596 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Fresh Frozen Plasma 3593691 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Fresh Frozen Plasma 5304297 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Fresh Frozen Plasma 3595085 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Fresh Frozen Plasma 3593691 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Red Blood Cells KX01047 Class II Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Fresh Frozen Plasma KX01047 Class II Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells KP29367 Class III Blood product, collected from a donor who did not meet acceptance criteria, was distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells Leukocytes Reduced W021607000599 Class III Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed. Department of the Navy
Biologics Red Blood Cells Leukocytes Reduced KP75541 Class III Blood product, collected from a donor whose body temperature was not documented, was distributed. San Diego Blood Bank
Biologics Source Plasma 4080307345, 4080304707, 4080302925, 4080302592, 4080301045, 4080300255, 4080299405, 4080298897, 4080297920, 4080297374, 4080296503, 4080294636, 4080293921, 4080292719, 4080291766, 4080290587, 4080289563, 4080288528, 4080287610, 4080286781, 4080285527, 4080284898, 4080283608, 4080282639, 4080281633, 4080280750, 4080279432, 4080278202, 4080277455, 4080276135, 4080275539, 4080274005, 4080273426, 4080272017, 4080271214, 4080269965, 4080269311, 4080267965, 4080267509, 4080265741, 4080265152, 4080263595, 4080263070, 4080261722, 4080261025, 4080259133, 4080257782, 4080257083, 4080255635, 4080254972,  ...
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Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Csl Plasma
Biologics Source Plasma 4080230278, 4080227918, 4080221282, 4080216664, 4080215290, 4080214606, 4080213281, 4080212687, 4080207359, 4080206207, 4080202459, 4080201975, 4080199969, 4080197473, 4080196893, 4080180169, 4080170428, 4080167977, 4080167627 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 0460054624, 0460054375, 0460053765, 0460053046, 0460052681, 0460052248, 0460050883, 0460050587, 0460050160, 0460049586, 0460049195, 0460048781, 0460048529, 0460047982, 0460047459, 0460047069, 0460046603, 0460046302, 0460045817, 0460045407, 0460044919, 0460044525, 0460044162, 0460043473, 0460043099, 0460042359, 0460041692, 0460041247, 0460040232, 0460039929, 0460038722, 0460038262, 0460037878, 0460036800, 0460036262, 0460035913, 0460035198, 0460034855, 0460034484, 0460033826, 0460033566, 0460033193, 0460032009, 0460031674, 0460031243, 0460030874, 0460030294, 0460030010, 0460029419, 0460028966,  ...
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Class III Blood products, collected from a deferred donor, were distributed. Octapharma Plasma, Inc.
Biologics Source Plasma 0481339420 0481187078 0481187843 0481190303 0481193163 0481194078 0481196270 0481197223 0481199788 0481201648 0481203129 0481204842 0481206527 0481208049 0481209704 0481211349 0481215561 0481216908 0481222347 0481224106 0481225744 0481232998 0481234244 0481238148 0481238941 0481241888 0481243843 0481245817 0481247374 0481249476 0481252118 0481253347 0481255700 0481256776 0481259566 0481260471 0481263204 0481264353 0481269330 0481270059 0481275956 0481277763 0481281134 0481286536 0481287435 0481293164 0481294166 0481296600 0481297433 0481299805 0481300688 0481306049 0481306855 0481309181 0481310231 0481312385 0481313382  ...
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Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Csl Plasma Inc
Food Chocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***". Lot Code: 4832B Class I Chocolate Covered Peanuts were mislabeled with Chocolate Covered Raisins label; therefore Peanut Allergen is not identified. Affected consignees were contacted in November, 2012. The Warrell Corporation
Biologics Bone UBO008514008211; UBO008514008011; UBO008514008111 Class III Human tissue allografts, mislabeled with extended expiration dates, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Devices CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. HPBBZP, HPDBFZ Class II During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. DePuy Spine, Inc.
Devices CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures HPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ, HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN, HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C, HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4 Class II During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. DePuy Spine, Inc.
Devices CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL Class II During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. DePuy Spine, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W036812635828- part A; W036812635828- part B Class II Blood products, which did not meet the acceptable product specifications, were distributed. OneBlood / dba CBCF
Food ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA. Lot number 0912164, exp 12/12 and 1110354, exp 10/14 Class I The recall was initiated due to discovery of the presence of milk components (milk protein(s) and lactose) despite labeling that incorrectly states it is free of milk components. Saratoga Therapeutics, LLC
Drugs SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588 Class I Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug Beamonstar Products
Drugs Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563 Class I Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug Beamonstar Products
Biologics Red Blood Cells Leukocytes Reduced W045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 7042343; 7022228; 6955463 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing W045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941; 7042343; 7022228; 6955463 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 2436253 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets 2559582 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2559582; 2366969; 2251960 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 2559582; 2551960; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812427152 Class III Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036812427152 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038113040525 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Florida's Blood Centers - Lake Park
Food Butter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3. N/A Class II Elevated coliform and standard plate count. Contoocook Creamery
Biologics Red Blood Cells Leukocytes Reduced W035213107399T Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213107399T Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Class II Laboratory software, with a defect or glitch, was distributed. Data Innovations, Inc.
Biologics Data Innovations Instrument Manager software Model - Versions 8.12.01 Software Version: 8.12.01 Class II Laboratory software, with a defect or glitch, was distributed. Data Innovations, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812575466; Class II Blood products, collected from an inelgible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036812845514; Class II Blood products, collected from an inelgible donor, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036812575466; Class III Blood products, collected from an inelgible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells 2466267; 1748931; Class II Blood products, collected from an inelgible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 2565869; Class II Blood products, collected from an inelgibile donor, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2922847; Class II Blood products, collected from an inelgibile donor, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2565869; 2514057; Class II Blood products, collected from an inelgibile donor, were distributed. OneBlood, Inc.
Biologics Typhoid Vi Polysaccharide Vaccine E12871; E12881; G04811; G05071; G05081; G11301 Class III Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed. Sanofi Pasteur, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813010029; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2438324; 2685776; W036809266093; W036810226326; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036809266093; W036810226326; W036813010029; Class III Blood products, collected from an ineligible donor, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036513020524; W036512129435; W036512096702 Class II Blood products, collected from an ineligible donor, were distributed. LifeShare Blood Centers
Devices LeGoo® Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo® Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Devices LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. All lot codes Class II Product contains particulates (fibers) Genzyme Corporation, A Sanofi Company
Food 1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Natural California Salted Pistachios, Net wt. 18 oz (510 g) UPC 847938032150, 5) terrafina Natural California Salted Pistachios, Net wt. 20 oz (568g) UPC 847938073214), 6) terrafina Natural Roasted Salted Pistachios, Net wt. 7 oz (198g) UPC 847938003211. Item numbers: 1) 3211 with Best before 10/1/2013 to 11/30/13, 2) 9321 with Best before 10/1/2013 to 11/30/13, 3) S321 with Best before 10/1/2013 to 11/30/13, 4) M321 with Best before 10/1/2013 to 11/30/13, 5) L321 with Best before 10/1/2013 to 11/30/13, 6) R321 with Best before 10/1/2013 to 11/30/13 Class I Potential Salmonella contamination. Terrafina
Food 1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistachios, Net wt. 13 oz (368g) UPC 847938063208, 3) terrafina Natural California Unsalted Pistachios, Net wt. 18 oz (510g) UPC 847938032051, 4) terrafina Natural California Unsalted Pistachios, Net wt. 20 oz (567 g) UPC 847938073207, 5) terrafina Natural California Unsalted Pistachios, Net wt. 7 oz (198g) UPC 847938003204. Item numbers: 1) 9320 with Best before 7/1/2013 to 1/31/14, 2) S320 with Best before 7/1/2013 to 1/31/14, 3) M320 with Best before 7/1/2013 to 1/31/14, 4) L320 with Best before 7/1/2013 to 1/31/14, 5) R320 with Best before 7/1/2013 to 1/31/14 Class I Potential Salmonella contamination. Terrafina
Biologics Cornea CW101654OD; CW101654OS Class III Human Corneas, recovered from a donor whose plasma dilution was not properly evaluated, were distributed. Eye Bank Of Wisconsin, Inc.
Biologics Cornea 20130020OD; 20130020OS; 20130040OD; 20130040OS; 20130040ODSW; 20130040OSSW; 20130073OD; 20130073OS; 20130077OD; 20130077OS Class III Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Biologics Cornea 20120136OD; 20120136OS Class II Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Biologics Cornea 20130076OD; 20130076OS Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Biologics Reagent Red Blood Cells N338; N339; N340; N341; R276; R277ZA; R278; CW249ZA; CW249ZB; CW250ZA; CW250ZB Class III Capture-R Ready plates, with higher rates of equivocal and unexpected positive reactions, were distributed. Immucor Inc
Biologics Red Blood Cells W036809286286; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036809286286; Class III Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Cryoprecipitated AHF, Pooled W036809813030; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pheresis Leukocytes Reduced 022LL72748; 022LL72748; Class II Blood product, mislabeled as leukoreduced, was distributed. American National Red Cross, Penn-Jersey Region
Biologics Blood and Blood Products for Reprocessing W041111105120G; Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Measles, Mumps and Rubella Virus Vaccine Live 0851AA Class III M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed. Merck Sharpe & Dohme Corp
Biologics Bone 0111510146; 0111510147; 0111510148; 0111510131; 0111510132; 0111510133; 0111510134; 0111510135; 0111510136; 0111510137; 0111510138; 0111510139; 0111510140; 0111510066; 0111510068; 0111510070; 0111510071; 0111510072; 0111510073; 0111510074; 0111510075; 0111510076; 0111510077; 0111510078; 0111510079; 0111510080; 0111510081; 0111510082; 0111510083; 0111510091; 0111510096; 0111510097; 0111510098; 0111510099; 0111510100; 0111510101; 0111510102; 0111510103; 0111510104; 0111510105; 0111510106; 0111510107; 0111510108; 0111510109; 0111510110; 0111510111; 0111510112; 0111510113; 0111510114; 0111510115;  ...
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Class II Human tissue allografts, associated with positive culture results, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Food Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109 All product still on the retail store shelf. Class II The product is being recalled for undeclared soy lecithin and soybean oil. Tortilleria Lupita, Inc.
Devices SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions. Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609. Class II The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. Stelkast Co
Devices ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA® Chemistry systems. Lots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014) Class II Siemens confirmed that the ADVIA® Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ± 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected.. Siemens Healthcare Diagnostics
Food Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587 Best By SEP-02-2013 Class III One lot Spinach Artichoke & Parmesan dip contains the ingredient and nutrition information for Caramelized onion dip. Both dips have the same allergens statement - Milk, Soy and Egg. La Terra Fina USA, Inc.
Food Baltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600 UPC 4750217602547 12-10-2013 Class I Baltic Sprats in Spicy Brine may be contaminated with Listeria monocytogenes. Zip International Group LLC.
Devices Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F. UPN # 001BPM4015140F0, Catalogue #BPM4015140F. Lot#'s 15778169, 15735527, 15774378, 15788826, 15812347, 15824636, 15825277, 15836626, 15873338, 15891705, 15931291, 15945240, 16057260. UPN# M001PCBM4015140F0, Catalogue #PCBM4015140F, Lot #15756145. UPN # M001PCBO4015140F0, Catalogue #PCBO4015140F, Lot #'s 15688199, 15992736, 16066536, 16141255. Class II Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device. Boston Scientific Corporation
Devices Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: " Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) " Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm " Readily accessible to the device " Light to moderate tortuosity of proximal vessel segment " Nonangulated lesion segment (< 45°) " Smooth angiographic contour " Absence of angiographically visible thrombus and/or calcification. UPN # Catalogue # Lot # H749CBM3400150 CBM340015 15777251, 15898645, 16125358. H749RB4400150 RB440015 15780571. H749CBO3400150 CBO340015 15854224. Class II Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device. Boston Scientific Corporation
Devices WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187. Class III The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open. Copan Italia
Food Dove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA Item #3265D Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND . lot code 317DAIDS01 Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND . The interior polypropylene bags are stamped with lot code 308 BC4CP02 which reflects the co-packer of the 8 oz bags (Cano acquired by Coregistics, Wheeling, IL 60090). Class I Cinnamon Dusted Dark Chocolate Almonds (Item Number: 3059D) were packaged in boxes labeled Fruit Collection (Item Number: 3265D), a mix of Dark Chocolate-Covered Cranberries, Blueberries, and Cherries. Dove Chocolate Discoveries Llc
Drugs CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14 Class II Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer. Teva Pharmaceuticals USA, Inc.
Food THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the "Gallon Cans"); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the "Pantry Cans"). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the Gallon Can has a metal lid that must be opened by a can opener. (1) The Gallon Cans may be ordered as single units or in six (6) can cases. (2) The Pantry Cans may be ordered as single units or in ten (10) can cases. Catalog numbers: (1) Gallon Cans - 21110; (2) Pantry Cans - 22110 Website ID numbers: (1) Gallon Cans - 660 (2) Pantry Cans - 584 Identified using Canning dates: 2009 - 07/15/09, 08/25/09, 09/25/09, 11/23/09, 12/15/09; 2010 - 02/13/10, 03/04/10, 03/10/10, 03/11/10, 04/06/10, 04/12/10, 04/23/10, 04/24/10, 05/10/10, 06/16/10, 06/17/10, 06/30/10, 07/14/10, 08/26/10, 08/27/10, 08/30/10,  ...
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Class III Thrive Foods is recalling certain lots of its 64 and 72 ounce cans of THRIVE 6 Grain Pancake Mix because this product contains ingredients that react over time and increase the pressure inside the can, which may cause cans to expand or bulge and increase the risk of sudden release of the pancake mix when the can is opened and could pose the risk of injury. Thrive Foods LLC
Food Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135) Lot Code 188 (Best By Date 07/07/14) Lot Code 190 (Best By Date 07/09/14) Lot Code 191 (Best By Date 07/10/14) Class III Justi's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter. Justin'S Nut Butter
Food Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612) Lot Code 191 (Best By Date 07/10/14) Lot Code 192 (Best By Date 07/11/14) Class III Justin's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter. Justin'S Nut Butter
Food Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree nuts. 10-10-13 Class III Potters Fine Foods LLC are recalling Potter's Crackers Classic White because of cross contamination with a Basil Walnut Presto Cracker dough. Even though there is an allergen statement on the Classic White tag for tree nuts, we initiated a voluntary recall. All 109 packages were accounted for. Potters Fine Foods, LLC
Devices Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Product # Lot Number 1620-109 0213216244 1620-109 0213216804 1620-109 0313217447 1620-109 0413219296 1620-109 0413219479 1620-109 0613222208 1620-509 0213216077 1620-509 0213216598 1620-509 0213216740 1620-509 0313217912 1620-509 0313217980 1620-509 0413219446 1620-509 0413219514 1620-509 0513220340 1620-509 0613222209 1620-509 0613222677 1620-509 0613222950 1620-609 0213216021 1620-609 0213216987 1620-609 0313218036 1620-609 0413218860 1620-709 0313217801 1620-709 0413218861 1620-709 0513220659 1620-709 0613222204 1620-709 0613222465 1620-709 0613223531 1620-709 0713224375 1624-109 0213216721 1624-109 0313218583 1624-109 0413219836 1624-109 0413219934 1624-109 0613222761 1624-109 0713223840 1624-509 0213216018 1624-509 0213217203 1624-509 0313217576 1624-509 0313218461 1624-509 0413219480 1624-509T 0213215841 1628-509 0213217207 1628-509 0413219845 1628-509 0513220335 1628-509 0513220422 1628-509 0613222210 1632-509 0213216079 1632-509  ...
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Class II A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility MicroAire Surgical Instruments, LLC
Devices Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Product # Lot Number 1600-020 0213215913 1600-020 0413220145 1600-020 0513220342 1600-020 0513220769 1600-020 0513220952 1600-020 0513221114 1600-020 0513221302 1600-020 0513221825 1600-020 0613222383 1600-020 0613222462 1600-021 0213216019 1600-021 0213217287 1600-021 0413218802 1600-021 0413219838 1600-021 0513220423 1600-021 0513220876 1600-021 0513221009 1600-021 0513221948 1600-021 0613222759  ...
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Class II A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility MicroAire Surgical Instruments, LLC
Food El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic. None listed in Attachment B. However, the outside markings on the label has an expiration date code 6/2012-6/2014 (Attachment #2 2 of 2 and in Memorandum Report dated June 14, 2013. Class III Kamar Deen AL Basham Apricot Dried Paste does not declare product identity in English. Greenland Trading Corp
Veterinary Pentosan Polysulfate Sodium (K9) 150 mg/ml aqueous solution for injection, for Veterinary Use only 10 mL Sterile amber vials Refrigerated Storage required. Item Code PENTOS-INJ007VC This preparation is dispensed with a prescription label, so each vial would be individually labeled with specific information containing not only the drug name, strength, etc. but also the patient name, prescriber name, and directions for use. Lot number 20130618@409, Beyond Use Date 12/15/2013 Class II Routine endotoxin testing of this batch indicated that the finished injection solution contained a concentration of endotoxins exceeding established endotoxin concentration limits. A second sample tested from this same lot confirmed the higher than expected endotoxin concentration. Wedgewood Village Pharmacy, Inc.
Devices DMLC IV-ERGO - Beam shaping block for Radiation Therapy. EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046 Class II Clinical mistreatment may occur when there are errors in the clinical work flow. Elekta, Inc.
Food Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package. Date code: 24NOV13C21 Class I Peanut Butter Cup Cookie Dough (refrigerated) is packaged in Chocolate Chip Cookie Dough packaging. Peanuts or peanut butter are not listed on the ingredient list or allergen statement. Conagra Inc
Food Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI no code informtion Class III State of Hawaii Issued a Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil. Crown Pacific Int'L Llc
Food H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case Product marked with "BEST BY 23APR2014" Class II Cartons of this product have been found to contain coconut shrimp. Coconut is not listed as an ingredient. The Seafood Exchange Of Fla
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