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High RiskFDA
Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of to...
Medical Devices·137,445 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic p...
Medical Devices·5,013 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+...
Medical Devices·146 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coa...
Medical Devices·1,972 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
CriticalFDA
Philips Healthcare Inc.
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Diagnostic Devices·752 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique,...
Diagnostic Devices·5 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I...
Cardiac Devices·6,044 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologiqu...
Diagnostic Devices·68 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, Q...
Diagnostic Devices·57 affected·May 22, 2012
CriticalFDA
Mexicantown Wholesale
MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz
Snacks & Candy·50 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI ...
Bakery & Grains·100 affected·May 21, 2012
CriticalFDA
Mexicantown Wholesale
Muffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2)...
Bakery & Grains·1 affected·May 21, 2012
CriticalFDA
Mexicantown Wholesale
MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
Bakery & Grains·126 affected·May 21, 2012
High RiskFDA
Taco Loco Products Inc
Salmon Wrap. Two wraps per package. Net Wt 8 oz
Seafood·480 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Bakery & Grains·150 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Bakery & Grains·10 affected·May 21, 2012
CriticalFDA
Mexicantown Wholesale
MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
Bakery & Grains·6 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
1) EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12, UPC: 9564000009 2)...
Bakery & Grains·1 affected·May 21, 2012
CriticalFDA
Mexicantown Wholesale
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Bakery & Grains·10 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
Bakery & Grains·40 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
Bakery & Grains·4 affected·May 21, 2012
RecallFDA
Mexicantown Wholesale
EMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Bakery & Grains·8 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
Bakery & Grains·50 affected·May 21, 2012
High RiskFDA
Mexicantown Wholesale
CONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (ME...
Bakery & Grains·1 affected·May 21, 2012
CriticalFDA
Mexicantown Wholesale
MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
Bakery & Grains·80 affected·May 21, 2012
RecallFDA
Mexicantown Wholesale
TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
Bakery & Grains·7 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN ...
Injectable Drugs·13 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; ...
Injectable Drugs·434 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML ...
Injectable Drugs·17 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODU...
Injectable Drugs·17 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·4 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40M...
Injectable Drugs·87 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT)
Injectable Drugs·2 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·2 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOH...
Injectable Drugs·3 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML ...
Injectable Drugs·208 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT ...
Drugs·64 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 10...
Ophthalmic Drugs·18 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)
Drugs·1 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·10 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJECTABLE 300 ML 360 ML 450 ML; PROCAINE HCL, P.F. 8% ...
Injectable Drugs·8 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIU...
Injectable Drugs·32 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0...
Injectable Drugs·1,079 affected·May 21, 2012