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High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)
Injectable Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL ...
Injectable Drugs·14 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS)
Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MC...
Injectable Drugs·21 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (...
Injectable Drugs·16 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50M...
Drugs·10 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELEL...
Injectable Drugs·72 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
Supplements·9 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFER...
Inhaled / Nasal Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 30...
Injectable Drugs·86 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·5 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)
Injectable Drugs·9 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ...
Injectable Drugs·21 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25...
Injectable Drugs·12 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION ...
Injectable Drugs·107 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT;...
Injectable Drugs·193 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
Injectable Drugs·10 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Getinge Usa Inc
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and d...
Medical Devices·8 affected·May 25, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Adva...
Diagnostic Devices·363 affected·May 25, 2012
High RiskFDA
Ge Healthcare, Llc
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or ...
Medical Devices·70 affected·May 24, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows eas...
Medical Devices·12 affected·May 24, 2012
High RiskFDA
Ekos Corporation
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-...
Surgical Devices·21,892 affected·May 24, 2012
High RiskFDA
Tree Top Inc - Selah Plant
Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR ...
Beverages·6,708 affected·May 23, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client application...
Diagnostic Devices·38 affected·May 23, 2012
High RiskFDA
Integra Limited
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in...
Medical Devices·108 affected·May 23, 2012
High RiskFDA
Stingray Surgical Products, Llc
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Han...
Surgical Devices·6,326 affected·May 23, 2012
High RiskFDA
Lma North America Inc
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotrac...
Medical Devices·18,799 affected·May 23, 2012
High RiskFDA
Best West Foods
Cheese Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code ...
Dairy·1,800 affected·May 22, 2012
High RiskFDA
Rong Chang Trading Llc Dba: Always Best
Frozen Half Shell Oysters(S) and Frozen Half Shell Oysters(M)
Seafood·288 affected·May 22, 2012
High RiskFDA
Best West Foods
Florentine Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food c...
Frozen Food·1,800 affected·May 22, 2012
High RiskFDA
World Finer Foods, Inc.
Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Prod...
Food·1,953 affected·May 22, 2012
High RiskFDA
Bliss Unlimited
Luna & Larry's Coconut Bliss Mocha Maca Crunch; UPC 8 96767 00143 1
Food·1,080 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique...
Diagnostic Devices·38 affected·May 22, 2012
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
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
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
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
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