The Recall Desk

Archive

August 2012 recalls

875 recalls were announced in August 2012.

What the numbers show

Critical
152
Severe
378
High
226
Moderate
99
Low
20

Of the 875 recalls this month scored against our rubric, 17% are Critical, 43% are Severe.

Which agencies issued them

101–200 of 875

  • HighFDA (Food)·F-1956-2012·2012-08-29

    Flywheel's Raisin Pies Recalled for Undeclared Soybean Oil and Wheat

    Flywheel's Pies is recalling Raisin Pies sold in Arkansas due to undeclared partially hydrogenated soybean oil and wheat.

    Product
    Raisin Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almon, Salt Pie…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2232-2012·2012-08-29

    Terumo Interface Module Recall for Data Transfer Malfunctions

    Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.

    Product
    Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1953-2012·2012-08-29

    Flywheel's Pies Recalls Peach Pies for Undeclared Allergens

    Flywheel's Pies is recalling Peach Pies sold in Arkansas due to undeclared soy lecithin, partially hydrogenated soybean oil, and wheat.

    Product
    Peach Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2226-2012·2012-08-29

    Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges

    Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.

    Product
    UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2012·2012-08-29

    GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection

    GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.

    Product
    GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1984-2012·2012-08-29

    Winn-Dixie Recalls Southern Home Cranberry Nut Trail Mix for Undeclared Soy

    Winn-Dixie is recalling Southern Home Cranberry Nut Antioxidant Blend trail mix because it contains undeclared soy lecithin.

    Product
    Southern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, SC 29662.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1947-2012·2012-08-29

    KT Specialty Foods Recalls Cheese Pizza Due to Temperature Control Issues

    KT Specialty Foods Inc. is recalling Cheese Pizza in Oregon and Washington because it was not kept at safe temperatures to prevent pathogen growth.

    Product
    Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1964-2012·2012-08-29

    Flywheel's Pies Recalls Blackberry Pies for Undeclared Soybean Oil and Wheat

    Flywheel's Pies is recalling Blackberry Pies sold in Arkansas due to undeclared partially hydrogenated soybean oil and wheat.

    Product
    Blackberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1968-2012·2012-08-29

    Breadfarm Recalls Fig Bars Due to Potential Metal Fragment Contamination

    Breadfarm is recalling bulk-packed Fig Bars because the wheat germ used in production was potentially contaminated with metal fragments.

    Product
    Fig Bars (Fig Newton style), bulk packed and refrigerated for individual sales.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2252-2012·2012-08-29

    AGFA Medical Image Storage Device Recall for Data Loss Risk

    AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.

    Product
    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2012·2012-08-29

    Siemens EasyLink Informatic System Recalled for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.

    Product
    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2012·2012-08-29

    Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating

    Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.

    Product
    Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2236-2012·2012-08-29

    GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard

    GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.

    Product
    OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1949-2012·2012-08-29

    KT Specialty Foods Recalls Veggie Pizza Due to Temperature Control Failure

    KT Specialty Foods Inc. is recalling 20 units of bulk Veggie Pizza in Oregon and Washington because the product lacked temperature control, posing a risk of pathogen growth.

    Product
    Veggie Pizza. Label is not provided. Product is packaged and delivered in bulk.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·12261·2012-08-29

    Cooper Lighting Recalls Shower Light Trim Due to Falling Hazard

    Cooper Lighting is recalling shower light trims because the trim and glass lens can fall from the ceiling, posing impact and laceration hazards.

    Product
    Shower light trim
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1954-2012·2012-08-29

    Flywheel's Pies Recalls Cherry Pies Due to Undeclared Allergens

    Flywheel's Pies is recalling cherry pies sold in Arkansas because they contain undeclared soy lecithin, soybean oil, and wheat.

    Product
    Cherry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1952-2012·2012-08-29

    Flywheel's Pies Recalls Apple Pies for Undeclared Allergens

    Flywheel's Pies is recalling apple pies sold in Arkansas due to undeclared soy lecithin, partially hydrogenated soybean oil, and wheat.

    Product
    Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES, PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2221-2012·2012-08-29

    GE Healthcare Recalls OEC 8800 Mobile X-ray Systems for Linearity Defect

    GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.

    Product
    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2249-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1655-2012·2012-08-29

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 231,270 Daytrana patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1658-2012·2012-08-29

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1659-2012·2012-08-29

    Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Tests

    Prometheus Laboratories is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2228-2012·2012-08-29

    Siemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing

    Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.

    Product
    Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2235-2012·2012-08-29

    Stryker Spine Recalls Instructions for Use Due to Sterile Marking Error

    Stryker Spine is recalling 40 units of Instructions For Use for TRIO+ Standard Post Screws because the front cover was incorrectly marked with a 'Sterile' logo.

    Product
    The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2224-2012·2012-08-29

    Biomet Oxford Gap Gauge Recalled Due to Drafting Error

    Biomet U.K., Ltd. is recalling 119 Oxford Gap Gauge instruments because a drafting error resulted in misleading dimensions on the product drawings.

    Product
    Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2225-2012·2012-08-29

    Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges

    Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.

    Product
    UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2248-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2012·2012-08-29

    Sunquest Laboratory SMART Software Recall for Incorrect Patient Data

    Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.

    Product
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1654-2012·2012-08-29

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 121,530 Daytrana patches because the release liner may be difficult to remove. The defect affects the patch's mechanical peel force.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2247-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a corporate merger.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2012·2012-08-29

    GE OEC Fluoroscopes Recalled for Snubber Board Safety Standard Non-Compliance

    GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.

    Product
    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2222-2012·2012-08-29

    Conformis iTotal CR Knee Replacement System Recalled for Labeling Addendum

    Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.

    Product
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2016-2012·2012-08-29

    Spartan Sandwich Spread Recalled for Undeclared Yellow # 5 Dye

    Spartan Central Kitchen is recalling 4oz sandwich spreads because the label failed to declare Yellow # 5 as an ingredient.

    Product
    Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1652-2012·2012-08-29

    Victus Recalls Misbranded Hipoglos Ointment Tubes in Florida

    Victus, Inc. is voluntarily recalling 1,535 tubes of Hipoglos Ointment in Florida because the product is misbranded.

    Product
    Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g)…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2261-2012·2012-08-29

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Gas Regulator Failure

    Galil Medical is recalling Visual-ICE Cryoablation Systems because gas regulators may fail, rendering the devices inoperable.

    Product
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2012·2012-08-29

    McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status

    McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.

    Product
    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1656-2012·2012-08-29

    Morton Sodium Chloride USP Recalled for Slightly High Bromide Levels

    Morton Salt Co. is recalling specific lots of Sodium Chloride USP due to slightly out-of-specification bromide levels.

    Product
    Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2246-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2243-2012·2012-08-29

    Sunquest Encompass Software Recalled for Daylight Saving Time Time Display Error

    Sunquest Information Systems is recalling Encompass software versions 2.4 and later because specimen collection times display one hour late during Daylight Saving Time.

    Product
    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2227-2012·2012-08-29

    Beckman Coulter Access Total T3 Reagent Recalled for Negative Bias

    Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.

    Product
    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V420000·2012-08-28

    NBC Truck Equipment Recalls Sure Power Battery Separator Devices

    NBC Truck Equipment is recalling 2007-2011 trucks with Sure Power battery separators that may overheat, causing smoke or fire.

    Product
    DODGE — DODGE, NBC TRUCK EQUIPMENT, MITSUBISHI DAKOTA, CHEVY C3500, FE180
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V418000·2012-08-28

    Extreme Boat Trailer Wheels Recalled for Potential Separation Risk

    Lippert Components is recalling 2011-2012 Extreme boat trailers equipped with specific Carlisle wheels that may not tighten to proper torque, posing a risk of wheel separation.

    Product
    EXTREME — EXTREME 28 FUSION, 29 DECK, 00 DONZI 26 ZX, 25 RAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V421000·2012-08-28

    ShowHauler Recalls 2009-2011 Motorhomes Due to Battery Separator Fire Risk

    ShowHauler is recalling 2009-2011 Motorhomes, Toter Coaches, and Garage Coaches because Sure Power battery separators may overheat, causing smoke or fire.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME, GARAGE COACH, TOTER COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·12259·2012-08-28

    Krylon Spray Paints Recalled by Sherwin-Williams for Fire Hazard

    Sherwin-Williams is recalling specific Krylon glaze and acrylic paints because the aerosol canisters can leak, posing a fire hazard if stored near ignition sources.

    Product
    Krylon® Triple Thick Crystal Clear Glaze and Krylon® Indoor/Outdoor Crystal Clear Acrylic Paint
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V416000·2012-08-28

    SJC Ambulance Recall for Loose Mounting Bolts

    SJC is recalling 2012 Marque and McCoy-Miller ambulances because improperly torqued mounting bolts could cause the ambulance box to detach, increasing injury risk in a crash.

    Product
    SJC — SJC MARQUE, MCCOY-MILLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V417000·2012-08-28

    Heartland RV Recalls Fifth Wheels Due to Propane Generator Defect

    Heartland is recalling 2011-2013 Elkridge and Bighorn Silverado fifth wheels because an incorrectly connected propane line may cause an explosion.

    Product
    HEARTLAND — HEARTLAND ELKRIDGE, BIGHORN SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12257·2012-08-28

    Eecycleworks Recalls Bicycle Brakes Due to Fall Hazard

    Eecycleworks is recalling about 400 'eebrake' model bicycle brakes because the bridge can crack, posing a fall hazard to riders.

    Product
    Bicycle brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12260·2012-08-28

    Sherwin-Williams Recalls Tree House Acrylic Coating Due to Fire Hazard

    Sherwin-Williams is recalling Tree House Studio Clear Acrylic Matte Coating because the aerosol canister can leak, posing a fire hazard if stored near ignition sources.

    Product
    Tree House Studio™ Clear Acrylic Matte Coating
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V414000·2012-08-23

    McClain Recalls 2011-2012 Boat Trailers Due to Wheel Torque Defect

    McClain Trailers is recalling 2011-2012 AT and ATT boat trailers because aluminum wheels may not tighten to proper torque, risking wheel separation.

    Product
    MCCLAIN — MCCLAIN ATT, AT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12255·2012-08-23

    Zest Garden Recalls Wilson & Fisher Bistro Sets Due to Fall Hazard

    Zest Garden is recalling Wilson & Fisher White Cast Bistro Sets because the chairs can break during normal use, posing a fall hazard.

    Product
    Wilson & Fisher White Cast Bistro Table and Chairs Set
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12746·2012-08-23

    Mansfield Plumbing Recalls Acrylic Bathtubs and Whirlpools Due to Fall Hazard

    Mansfield Plumbing Products is recalling about 100 acrylic bathtubs, whirlpools, and air massage bathtubs because the grab bars can loosen and break, posing a fall hazard.

    Product
    Acrylic Bathtubs, Whirlpools and Air Massage Bathtubs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2062-2012·2012-08-22

    Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk

    Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.

    Product
    Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2061-2012·2012-08-22

    Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality

    Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.

    Product
    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1940-2012·2012-08-22

    Hannaford Meatball Panini Recalled for Potential Listeria Contamination

    Hannaford Bros. is recalling cold and hot Meatball Paninis because they contain meatballs recalled for potential Listeria monocytogenes.

    Product
    Hannaford Meatball Panini - cold, UPC # 941260723096 Hannaford Meatball Panini - hot, UPC # 94126072102 Packaged in 10 oz plastic clamshell
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-2063-2012·2012-08-22

    Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.

    Product
    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2064-2012·2012-08-22

    Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.

    Product
    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1941-2012·2012-08-22

    St Clair Foods Recalls Sliced Yellow Onions for Listeria Risk

    St Clair Foods is recalling 4/5 SYS Sliced Yellow Onions distributed by Sysco in Tennessee due to potential Listeria monocytogenes contamination.

    Product
    4/5 SYS SLICED YELLOW ONIONS, 720621 SUPC 1232222, Distributed by: SYSCO
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1939-2012·2012-08-22

    Publix Recalls Custom Sub Sandwiches Due to Listeria Risk

    Publix Super Markets is voluntarily recalling custom-made sub sandwiches containing onions sold in specific states due to potential Listeria monocytogenes contamination.

    Product
    NO LABEL. Sub sandwiches are prepared fresh - made to order - wrapped in paper and then a generic label applied. The scale label would only state 1/2 sub or whole sub and the price from the Publix Deli. Publix does not have a mechanism to track sub sandwiches prepared with…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1614-2012·2012-08-22

    Franck's Lab Recalls Sterile Rubidium Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.

    Product
    RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1489-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Contamination

    Franck's Lab Inc. is recalling specific sterile ophthalmic drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1556-2012·2012-08-22

    Franck's Lab Recalls Sterile Levofloxacin Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile levofloxacin injectable solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE 300 ML 500 ML (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1624-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs, including Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1632-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1578-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1476-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.

    Product
    BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1604-2012·2012-08-22

    Franck's Lab Recalls Povidone-Iodine Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific povidone-iodine ophthalmic solutions because FDA testing found microorganisms in the production clean room.

    Product
    POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1550-2012·2012-08-22

    Franck's Lab Recalls Isosulfan Blue Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Isosulfan Blue 1% Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2012·2012-08-22

    Franck's Lab Recalls Baclofen Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Baclofen drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    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) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1635-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1599-2012·2012-08-22

    Franck's Lab Recalls Sterile Phenylephrine Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile phenylephrine injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1637-2012·2012-08-22

    Franck's Lab Recalls Sterile Vanadyl Sulfate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile Vanadyl Sulfate Solution injectable because FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1608-2012·2012-08-22

    Franck's Lab Recalls Sterile Progesterone Injections Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile progesterone injections distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2012·2012-08-22

    Franck's Lab Recalls Acetazolamide Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1485-2012·2012-08-22

    Franck's Lab Recalls Cisplatin Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1547-2012·2012-08-22

    Franck's Lab Recalls Sterile Insulin Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile insulin products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2012·2012-08-22

    Recall of Sterile Ketorolac Tromethamine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ketorolac tromethamine injectable products because environmental sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1501-2012·2012-08-22

    Franck's Lab Recalls Sterile Diazepam Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile diazepam injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA testing found microorganisms in the production clean room.

    Product
    BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1598-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1457-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling 19 units of sterile injectable drugs, including ascorbic acid and vitamin blends, because FDA sampling found microorganisms in the production clean room.

    Product
    ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1619-2012·2012-08-22

    Franck's Lab Recalls Strontium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.

    Product
    STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1584-2012·2012-08-22

    Franck's Lab Recalls Sterile Molybdenum Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile molybdenum injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1515-2012·2012-08-22

    Franck's Lab Recalls Sterile Estradiol Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling 72 units of sterile estradiol products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    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 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1526-2012·2012-08-22

    Franck's Lab Recalls Sterile Ganciclovir Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Ganciclovir injectable syringes because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.

    Product
    BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions

    Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.

    Product
    BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1516-2012·2012-08-22

    Franck's Lab Recalls Sterile Ethyl Alcohol Injections Due to Contamination

    Franck's Lab Inc. is recalling sterile ethyl alcohol injections because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1546-2012·2012-08-22

    Franck's Compounding Lab Recalls Indocyanine Green Injectable Kits Due to Sterility Concerns

    Franck's Compounding Lab is recalling Indocyanine Green injectable kits because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1449-2012·2012-08-22

    Franck's Lab Recalls Acetylcysteine Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific acetylcysteine ophthalmic solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1542-2012·2012-08-22

    Franck's Lab Recalls Sterile Hydromorphone/Clonidine Intrathecal Drugs

    Franck's Lab Inc. is recalling specific sterile hydromorphone/clonidine intrathecal drugs due to microorganisms and fungal growth found in the clean room.

    Product
    HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1591-2012·2012-08-22

    Franck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1506-2012·2012-08-22

    Franck's Lab Recalls Sterile DMSO and Heparin Solutions Due to Contamination

    Franck's Lab Inc. is recalling specific sterile DMSO and Heparin solutions because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide

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