The Recall Desk

Archive

February 2014 recalls

473 recalls were announced in February 2014.

What the numbers show

Critical
14
Severe
98
High
222
Moderate
120
Low
19

Of the 473 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

Which agencies issued them

201–300 of 473

  • ModerateFDA (Devices)·Z-0939-2014·2014-02-19

    RTI Surgical Recalls OPTEFORM Allograft Paste Due to Incorrect Dispenser

    RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.

    Product
    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Resea
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0966-2014·2014-02-19

    Neuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance

    Neuro Kinetics is recalling 148 Normative Data Template CDs for I-Portal devices because the data has not received FDA clearance through the 510(k) process.

    Product
    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0940-2014·2014-02-19

    Siemens ADVIA Chemistry Systems Recalled for Software Calibration Defect

    Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.

    Product
    Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2014·2014-02-19

    Actavis Recalls Trelstar Injectable Suspension Due to Labeling Error

    Actavis is recalling 99 cartons of Trelstar 11.25 mg due to a labeling error where the vial was marked 3.75 mg. The product was distributed nationwide and in Puerto Rico.

    Product
    Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1084-2014·2014-02-19

    Mylan Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Testing Failures

    Mylan Pharmaceuticals is recalling specific lots of Levothyroxine Sodium Tablets because stability testing showed the drug was below specification.

    Product
    Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0975-2014·2014-02-19

    Stryker Recalls Incorrect Patient-Specific Customized Implant Kit

    Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.

    Product
    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or cr
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0977-2014·2014-02-19

    Medtronic GRAFTON DBM Flex Recalled for Incorrect Product Dimensions

    Medtronic is recalling GRAFTON DBM Flex units labeled as 2.5 cm x 10 cm that actually measure 2.5 cm x 5 cm.

    Product
    Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0941-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2014·2014-02-19

    Bracco Recalls VoLumen Barium Sulfate Suspension Due to Stability Failure

    Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension because the product failed stability testing for preservative content.

    Product
    VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0965-2014·2014-02-19

    Bio-Rad D-10 Hemoglobin Testing System Software Recall

    Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.

    Product
    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E004000·2014-02-18

    Aisin Automatic Transmission Recall for Power Loss Risk

    Aisin World Corp. of America is recalling specific automatic transmissions for Isuzu and Chrysler vehicles due to a loose snap ring that may cause a loss of power transfer.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V086000·2014-02-18

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Fire Risk

    PACCAR is recalling specific 2014-2015 Kenworth and Peterbilt tractor trailers because condensation in the intake manifold may freeze, causing exhaust flames and increasing the risk of fire or burn injury.

    Product
    KENWORTH — KENWORTH, PETERBILT T660, T800, W900, T440
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V060000·2014-02-18

    Diamond Coach Recalls 2009-2010 VIP/PT Transit Buses for Fire Risk

    Diamond Coach is recalling 2009-2010 VIP/PT transit buses because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.

    Product
    VIP/PT — VIP/PT 2800, 3200, 3201, 2200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V069000·2014-02-18

    Gulf Stream GT GulfTran Shuttle Recall for Door Actuator Fire Risk

    Gulf Stream Coach is recalling 2011 GT GulfTran shuttles because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.

    Product
    GULF STREAM — GULF STREAM GT GULFTRAN SHUTTLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14106·2014-02-18

    LEM 5-Tray Food Dehydrators Recalled for Electrical Shock Hazard

    LEM Products is expanding a recall of 5-tray food dehydrators due to damaged wiring that poses a shock hazard. Consumers should stop using the units and contact the company for repair.

    Product
    5-Tray Dehydrators with Digital Timers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14715·2014-02-18

    Club Car Recalls Precedent I2 Golf Vehicles Due to Fall Hazard

    Club Car is recalling about 1,800 Precedent I2 golf and transport vehicles because the passenger-side hip restraint can fracture, posing a fall hazard.

    Product
    Precedent I2 golf and transport vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·015-2014·2014-02-15

    Nutriom Recalls Dried Egg Products Due to Possible Salmonella Contamination

    Nutriom LLC is recalling approximately 226,710 pounds of dried egg products due to possible Salmonella contamination. The products were shipped nationwide, to U.S. military installations, and to Canada.

    Product
    Washington Firm Recalls Dried Egg Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·013-2014·2014-02-14

    Rancho Feeding Recalls Uninspected Beef Products Due to Adulteration

    Rancho Feeding Corporation is recalling approximately 8.7 million pounds of beef products because they were processed without full federal inspection.

    Product
    California Firm Recalls Unwholesome Meat Products Produced Without the Benefit of Full Inspection
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·14V056000·2014-02-14

    Honda Recalls 2013 CB500 and CBR500 Motorcycles for Engine Bolt Defect

    Honda is recalling 2013 CB500 and CBR500 motorcycles because rocker arm shaft retaining bolts may loosen, causing oil leaks and potential engine stalls.

    Product
    HONDA — HONDA CB500F, CBR500RA, CB500XA, CBR500R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E003000·2014-02-14

    Cummins Westport Engine Recall for Intake Manifold Sensor Defect

    Cummins is recalling Westport ISL G and ISX12 G engines because condensation in the intake manifold may freeze and interfere with the pressure sensor, potentially causing exhaust fires or burns.

    Product
    ENGINE AND ENGINE COOLING:ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1054-2014·2014-02-12

    B. Braun Recalls Cefepime Injection Due to Visible Organic Particulate Matter

    B. Braun Medical Inc. is recalling 18,936 containers of Cefepime Hydrochloride and Dextrose Injection due to the presence of visible organic particulate matter.

    Product
    CEFEPIME HYDROCHLORIDE AND DEXTROSE — CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1467-2014·2014-02-12

    Flat Creek Farm Heavenly Blue Cheese Recalled for Salmonella

    Flat Creek Farm & Dairy is recalling Heavenly Blue cheese after routine testing revealed the presence of Salmonella.

    Product
    Heavenly Blue cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 8 lbs). Labeled in part: "367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE HEAVENLY BLUE Raw milk, salt,***130916XHB".
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1472-2014·2014-02-12

    Marina's German Bakery Recalls Assorted Pastries Due to Undeclared Tree Nuts

    Marina's German Bakery is recalling assorted pastries because they may contain undeclared hazelnuts, walnuts, or almonds, posing a risk of allergic reactions.

    Product
    Marina's German Bakery; Assorted Pastries; 2 pieces, Minimum Wt. 6 oz. 170 g; UPC# 010801003018; 2033 Trawood Dr., El Paso, Texas 79935
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0905-2014·2014-02-12

    Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect

    Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.

    Product
    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1466-2014·2014-02-12

    Flat Creek Farm Recalls Aztec Cheddar Cheese Due to Salmonella

    Flat Creek Farm & Dairy is recalling Aztec Cheddar Cheese after routine testing revealed the presence of Salmonella. The product was distributed in Georgia and Florida.

    Product
    Aztec Cheddar Cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 13 lbs). Labeled in part: "367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE AZTEC CHEDDAR Raw milk, salt,***130823XCAZ"
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1061-2014·2014-02-12

    Teva Recalls Valacyclovir Tablets Due to Potential Foreign Tablet Fragments

    Teva Pharmaceuticals USA is recalling Valacyclovir Hydrochloride 1 g tablets because bottles may contain fragments of Pravastatin tablets.

    Product
    Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1470-2014·2014-02-12

    Triarco Recalls Green Lightening Drink Granulation Due to Chloramphenicol Contamination

    Triarco Industries is recalling Green Lightening Drink Granulation that may be contaminated with Chloramphenicol. The product is for manufacturing use only.

    Product
    Triarco Industries, LLC an Innophos company Green Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V052000·2014-02-12

    Nissan Recalls 2012-2014 Frontier Vehicles for Wiring Fire Risk

    Nissan is recalling 2012-2014 Frontier vehicles because an incorrectly installed circuit breaker may cause a wire harness to contact a metal bolt, potentially leading to an electrical short and fire.

    Product
    NISSAN — NISSAN FRONTIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1066-2014·2014-02-12

    Apothecure Recalls Sterile Compounded Products Due to Sterility Assurance Concerns

    Apothecure, Inc. is recalling all lots of sterile compounded products within expiry due to lack of sterility assurance identified during an FDA inspection.

    Product
    The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1057-2014·2014-02-12

    Baxter Recalls Nitroglycerin Injection Due to Particulate Matter

    Baxter Healthcare is recalling 49,932 vials of Nitroglycerin in Dextrose Injection because particulate matter was found in one vial.

    Product
    NITROGLYCERIN IN DEXTROSE — NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1067-2014·2014-02-12

    Health & Beyond Tranquility Supplement Recalled for Unapproved Prescription Drugs

    Health & Beyond is recalling Tranquility dietary supplements because they contain unapproved prescription drugs, Doxepin and Chlorpromazine.

    Product
    HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0908-2014·2014-02-12

    Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients

    Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.

    Product
    Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1471-2014·2014-02-12

    Triarco Activessence Recalled for Potential Chloramphenicol Contamination

    Triarco Industries is recalling Activessence, a manufacturing ingredient, due to potential contamination with Chloramphenicol.

    Product
    Triarco Industries, LLC an Innophos company Activessence (R) Notice- For Manufacturing Use Only Not for Resale
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1469-2014·2014-02-12

    Triarco Red Lightening Drink Granulation Recalled for Chloramphenicol Contamination

    Triarco Industries is recalling Red Lightening Drink Granulation due to potential contamination with Chloramphenicol. The product is for manufacturing use only.

    Product
    Triarco Industries, LLC an Innophos company Red Lightening Drink Granulation Notice- For manufacturing Use Only Not for Resale
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1468-2014·2014-02-12

    Triarco Multicolor Lightening Drink Granulation Recalled for Chloramphenicol Contamination

    Triarco Industries is recalling Multicolor Lightening Drink Granulation due to potential Chloramphenicol contamination. The product is for manufacturing use only.

    Product
    Triarco Industries, LLC an Innophos company Multicolor Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0925-2014·2014-02-12

    CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues

    CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.

    Product
    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2014·2014-02-12

    CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak

    CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.

    Product
    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2014·2014-02-12

    GE Healthcare Recalls Stand-Alone Resuscitation T-Pieces Due to Loose Knob

    GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road La
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits

    GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2014·2014-02-12

    Ossur Recalls Symbionic Leg Prostheses Due to Electronics Defect

    Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.

    Product
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0911-2014·2014-02-12

    GE Healthcare Recalls X-ray Systems Due to Monitor Suspension Nut Issue

    GE Healthcare is recalling Precision 500D, MPI, and RXI X-ray systems because a locking nut on the overhead monitor suspension may loosen.

    Product
    GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V071000·2014-02-12

    Three Feathers Recalls Trailers With Defective Door Locks

    Three Feathers is recalling 480 trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    THREE FEATHERS — THREE FEATHERS MULE CARGO HAULER, PELICAN CARGO HAULER, PINECONE TEAR DROP TRLR, TUMBLEWEED CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2014·2014-02-12

    Siemens SOMATOM CT Systems Recalled for Potential Display Freeze Malfunction

    Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.

    Product
    Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2014·2014-02-12

    B. Braun AccuFlo Elastomeric Infusion Pump Recalled for Flow Rate Issues

    B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.

    Product
    B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0918-2014·2014-02-12

    Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers

    Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.

    Product
    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2014·2014-02-12

    GE Healthcare Panda Infant Warmers Recalled for Loose Adjustment Knob

    GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V072000·2014-02-12

    R&M Trailer Recalls 2012-2013 Enclosed Cargo Trailers Due to Door Lock Defect

    R&M Trailer is recalling 185 model year 2012-2013 enclosed cargo trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.

    Product
    R&M TRAILER — R&M TRAILER 6X12 ENCLOSED CARGO, 7X16 ENCLOSED CARGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2014·2014-02-12

    GE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss

    GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.

    Product
    CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1465-2014·2014-02-12

    Lenguita Cookies Recalled for Undeclared Wheat Allergen

    Gotera, Inc is recalling Lenguita Cookies because the product contains undeclared wheat. The recall affects 217 cases distributed across nine states.

    Product
    Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email [email protected] www.mamalycha.com Product of Honduras
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0912-2014·2014-02-12

    GE Healthcare Recalls Giraffe Infant Warmers Due to Loose Adjustment Knob

    GE Healthcare is recalling 1,970 Giraffe Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own phys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2014·2014-02-12

    ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results

    ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.

    Product
    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2014·2014-02-12

    Elekta XiO RTP System Recalled for Incorrect Effective Depth Calculation

    Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.

    Product
    XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14105·2014-02-12

    MAT Industries Recalls HDX and Powermate Air Compressors Due to Shock Hazard

    MAT Industries is recalling HDX and Powermate two-gallon air compressors because pressure switch terminals can contact the motor housing, posing a shock hazard.

    Product
    HDX™ and Powermate® two-gallon air compressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14104·2014-02-12

    Visonic Amber Personal Emergency Response Kits Recalled for Signal Failure

    Visonic Amber SelectX kits are recalled because base stations may fail to detect emergency signals after a reboot. No injuries have been reported.

    Product
    Visonic Amber SelectX Personal Emergency Response System (PERS) Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2014·2014-02-12

    ArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction

    ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.

    Product
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2014·2014-02-12

    OrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error

    OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.

    Product
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1074-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.

    Product
    Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2014·2014-02-12

    Exactech Recalls InteGrip Acetabular Augments Due to Biological Evaluation Failure

    Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.

    Product
    ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0922-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0935-2014·2014-02-12

    Zest Anchors Recalls Locator Implant Attachment Systems Due to Labeling Error

    Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.

    Product
    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by end
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1062-2014·2014-02-12

    Children's Ibuprofen Recalled for Abnormal Appearance and Discoloration

    Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen Oral Suspension due to discoloration and failure to meet appearance specifications.

    Product
    CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0910-2014·2014-02-12

    Nipro Diagnostics Recalls TRUEtrack Blood Glucose Monitors Due to Unit Error

    Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2014·2014-02-12

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets

    Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol tablets because some tablets are broken.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2014·2014-02-12

    Corepharma Recalls Pyridostigmine Bromide Tablets Due to Dissolution Failure

    Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP 60 mg because they failed a dissolution test at the 30-month stability time point.

    Product
    Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1056-2014·2014-02-12

    Insight Instruments Recalls Cornea Coat Hydroxypropylmethylcellulose Syringes

    Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.

    Product
    Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1080-2014·2014-02-12

    Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0920-2014·2014-02-12

    Fresenius Bicarbonate Jug Adapter Recalled for Premature Distribution

    Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.

    Product
    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1077-2014·2014-02-12

    FAMILY wellness Triple Antibiotic Ointment Recalled for Microbial Contamination

    Faria Limited LLC is recalling FAMILY wellness Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

    Product
    FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2014·2014-02-12

    Philips Diagnostic Imaging Systems Recalled for Database Lockup

    Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.

    Product
    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Drugs)·D-1064-2014·2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures

    Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.

    Product
    Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0923-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Orthodontic Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1076-2014·2014-02-12

    Sheffield Triple Antibiotic Ointment Recalled for Microbial Contamination

    Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

    Product
    SHEFFIELD TRIPLE ANTIBIOTIC — SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0904-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA N Control for Revised Potassium Values

    Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.

    Product
    ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2014·2014-02-12

    Stryker Recalls Gaymar Medi-Therm Devices Due to Missing Water Temperature Display

    Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.

    Product
    The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0909-2014·2014-02-12

    Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings

    Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2014·2014-02-12

    Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade

    Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.

    Product
    Neptune 2 Rover Ultra Waste Management System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.

    Product
    Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1059-2014·2014-02-12

    Greenstone Recalls Glipizide XL Tablets Due to Dissolution Failure

    Greenstone LLC is recalling 22,529 bottles of Glipizide XL 5 mg tablets because a bulk lot failed a dissolution specification test.

    Product
    Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1063-2014·2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures

    Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.

    Product
    Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2014·2014-02-12

    Pfizer Recalls Glucotrol XL Tablets for Dissolution Specification Failure

    Pfizer is recalling specific bottles of Glucotrol XL tablets because they failed to meet dissolution specifications at the 8-hour stability timepoint.

    Product
    Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1069-2014·2014-02-12

    PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects

    PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1068-2014·2014-02-12

    PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects

    PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1073-2014·2014-02-12

    PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Exterior Residue

    PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1070-2014·2014-02-12

    PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Container Defects

    PACK Pharmaceuticals is recalling specific lots of Timolol Maleate eye drops because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0924-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA Urine Control L/H for Creatinine Range Update

    Horiba Medical is recalling ABX PENTRA Urine Control L/H because the target range for the Creatinine assay was updated. The recall affects 531 units distributed in the US and Canada.

    Product
    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels
    Category
    Medical Device
    Distribution
    Distributed nationwide

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