The Recall Desk

Archive

August 2014 recalls

458 recalls were announced in August 2014.

What the numbers show

Critical
18
Severe
90
High
160
Moderate
169
Low
21

Of the 458 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

Which agencies issued them

301–400 of 458

  • ModerateFDA (Drugs)·D-1511-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations

    Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1522-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2014·2014-08-13

    BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution

    BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.

    Product
    VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-1513-2014·2014-08-13

    Wockhardt Recalls BuPROPion HCl Extended-Release Tablets Due to Impurity Levels

    Wockhardt USA is recalling 840 bottles of buPROPion HCl Extended-Release Tablets because out-of-specification levels of the impurity m-chlorobenzoic acid were observed.

    Product
    buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2138-2014·2014-08-13

    Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure

    Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.

    Product
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1517-2014·2014-08-13

    SST Corporation Recalls Tetrahydrozoline HCL Due to CGMP Deviations

    SST Corporation is recalling Tetrahydrozoline HCL drums because they were stored in a non-GMP compliant warehouse in Italy.

    Product
    Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2144-2014·2014-08-13

    Zimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error

    Zimmer, Inc. is recalling Tapered Screw-Vent Dental Implants because the inner vial is labeled with incorrect dimensions.

    Product
    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1518-2014·2014-08-13

    Alcohol-Free Hand Sanitizer Recalled for Microbial Contamination

    HLI dba Humphreyline Inc is recalling 975 bottles of alcohol-free hand sanitizer due to microbial contamination. The product was distributed in Kentucky, Maryland, and Virginia.

    Product
    Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Com
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2150-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1510-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1525-2014·2014-08-13

    Medical Supply Liquidators Recalls Unapproved MIC Injection Vials

    Medical Supply Liquidators LLC is recalling MIC Injection USP vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2143-2014·2014-08-13

    Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment

    Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.

    Product
    Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2142-2014·2014-08-13

    Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement

    Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.

    Product
    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1516-2014·2014-08-13

    Novartis Recalls Cataflam Tablets Due to Illegible Ink Identification

    Novartis is recalling 50 bottles of Cataflam (diclofenac potassium) 50 mg tablets because ink identification rubbed off during transit, making them illegible.

    Product
    Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2154-2014·2014-08-13

    Teleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error

    Teleflex Medical is recalling 720 RUSCH Foley Urinary Catheter Insertion Trays because the expiration date is incorrectly printed as the same as the manufacturing date.

    Product
    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V705000·2014-08-12

    Blue Bird Recalls 2015 School Buses Due to Fuel Filter Defect

    Blue Bird is recalling 2015 All American and Vision school buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T010000·2014-08-12

    TBC Recalls Wild Country Radial Tires Due to Sidewall Cracking

    TBC Corporation is recalling specific Wild Country Radial XTX Sport tires due to sidewall cracking that could lead to sudden air loss and a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14254·2014-08-12

    CoScentrix Recalls DD Brand Tin Candles Due to Fire Hazard

    CoScentrix is recalling DD Brand tin candles sold at Hobby Lobby because the high flame can ignite the wax and container, posing a fire hazard.

    Product
    DD Brand Tin Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·052-2014·2014-08-12

    Applegate Recalls Chicken Nuggets Due To Possible Plastic Contamination

    Applegate is recalling frozen chicken nuggets due to possible plastic contamination. No illnesses or injuries have been reported.

    Product
    Gold Creek Foods, LLC — Georgia Firm Recalls Chicken Nugget Product Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T009000·2014-08-11

    Continental Recalls Motorcycle Tires Due to Tread Separation Risk

    Continental is recalling specific motorcycle tires because the tread, belt, and carcass may separate, causing a loss of inflation pressure and increasing crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V496000·2014-08-11

    Versalift Recalls Ford Super Duty Trucks with Fire Risk

    Versalift is recalling 2009-2013 Ford Super Duty trucks equipped with specific PTO assemblies due to a risk of fire from oil leaking onto the exhaust.

    Product
    FORD — FORD F-550 SUPER DUTY, F-350 SUPER DUTY, F-450 SUPER DUTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V495000·2014-08-11

    Ford Recalls 2013-2014 Focus and Escape Vehicles for Wiring Defect

    Ford is recalling 2013-2014 Focus ST and Escape vehicles with 2.0-liter engines because a wiring defect may cause the engine to stall, increasing crash risk.

    Product
    FORD — FORD FOCUS, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·051-2014·2014-08-09

    Oberto's Recalls Chicken Strips Due to Quality Control Issues

    Oberto's Brands is recalling approximately 57,578 pounds of chicken strips due to a company quality issue involving increased water activity.

    Product
    Recall Notification Report 051-2014
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V490000·2014-08-08

    General Motors Recalls 2002-2004 Saturn Vues for Ignition Key Defect

    General Motors is recalling 2002-2004 Saturn Vues because the key may be removed from the ignition while the vehicle is not in the Off position, creating a risk of the vehicle rolling away.

    Product
    SATURN — SATURN VUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E052000·2014-08-08

    Lippert Recalls Recreational Vehicle Frames With Defective Spring Hangers

    Lippert is recalling certain recreational vehicle frames manufactured in February 2014 because the spring hangers may fracture, potentially causing loss of vehicle control.

    Product
    STRUCTURE:FRAME AND MEMBERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V491000·2014-08-08

    All Wheel Recalls 2011-2012 Ford F-550 Chassis Due to Fire Risk

    All Wheel is recalling 2011-2012 Ford F-550 Super Duty chassis with 6.8L gasoline engines due to a PTO oil leak that poses a fire risk.

    Product
    SUPER DUTY — SUPER DUTY F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V494000·2014-08-08

    Vanair Recalls Ford Super Duty Trucks Due to Fire Risk

    Vanair is recalling 2009-2013 Ford F-350, F-450, and F-550 Super Duty trucks modified with specific air compressor systems because oil leaks may cause a fire.

    Product
    FORD — FORD F-450 SUPER DUTY, F-550 SUPER DUTY, F-350 SUPER DUTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V488000·2014-08-08

    GM Recalls 2013 Buick Encore and Cadillac ATS for Seat Belt Defect

    General Motors is recalling 2013 Buick Encore and Cadillac ATS vehicles because front lap belt pretensioner cables may not lock, increasing injury risk in a crash.

    Product
    CADILLAC — CADILLAC, BUICK ATS, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V489000·2014-08-08

    GM Recalls 2014-2015 Chevrolet Impala for Storage Console Latch Defect

    General Motors is recalling 2014-2015 Chevrolet Impala vehicles because the center storage console may not stay latched during a crash, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V487000·2014-08-07

    Ferrari Recalls 458 Models for Front Trunk Latch Defect

    Ferrari is recalling 2010-2014 458 models because the front trunk latch may not release, violating safety standards and increasing injury risk.

    Product
    FERRARI — FERRARI 458
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V486000·2014-08-07

    PACCAR Recalls 2015 Kenworth and Peterbilt Trucks for Fuel Filter Defect

    PACCAR is recalling 2015 Kenworth and Peterbilt trucks because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T440, W900, 348, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14252·2014-08-07

    Lea Industries Recalls Lighted Night Stands Due to Burn Hazard

    Lea Industries is recalling about 520 lighted night stands sold in the U.S. and Canada because the under-lighting can overheat and scorch carpets, posing a burn hazard.

    Product
    Lea lighted night stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14742·2014-08-07

    L.L. Bean Recalls Children's Sweaters Due to Choking Hazard

    L.L. Bean is recalling specific children's sweaters because a spare button can detach and pose a choking hazard. No injuries have been reported.

    Product
    Fisherman's and Open Stitch Children's Sweaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1509-2014·2014-08-06

    Sandoz Recalls Alprazolam Tablets Due to Stainless Steel Particulates

    Sandoz Incorporated is recalling 1,332 bottles of Alprazolam 0.25mg tablets nationwide because they may contain stainless steel metal particulates.

    Product
    ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2233-2014·2014-08-06

    Richards Too Good BBQ Sauce Recalled for Botulism Risk

    Richard's Rub & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Hot Sauce, and Teriyaki Sauce due to potential Clostridium botulinum contamination.

    Product
    Richards Too Good BBQ Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2226-2014·2014-08-06

    Sequatchie Cove Creamery Recalls Cumberland Cheese Due to E. Coli

    Sequatchie Cove Creamery is recalling Cumberland cheese because an FDA sample tested positive for generic E. coli.

    Product
    SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN 37374
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V483000·2014-08-06

    Ford Recalls 2015 Transit Vans for Sliding Door Defect

    Ford is recalling 2015 Transit cargo vans because windowless sliding doors may lack epoxy reinforcement, increasing the risk of occupant ejection in a side impact crash.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2239-2014·2014-08-06

    Whole Foods Mesclun Goat Cheese Salad Recalled for Undeclared Allergens

    Whole Foods Market Group Inc. is recalling Mesclun Goat Cheese Salad Mini because product labels were switched, resulting in undeclared fish and tree nuts.

    Product
    Whole Foods Mesclun Goat Cheese Salad Mini Net Wt 4 0z plastic shell
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1500-2014·2014-08-06

    Jubilant Cadista Recalls Losartan Potassium and Hydrochlorothiazide Tablets

    Jubilant Cadista Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets due to the presence of stainless steel blemishes.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V482000·2014-08-06

    Ford Recalls 2015 Transit Vans for Rear Brake Fluid Leak Risk

    Ford is recalling 2015 Transit vehicles because brake fluid may leak from rear caliper junctions, potentially increasing stopping distance or causing complete braking loss.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2235-2014·2014-08-06

    Richard's Too Good Teriyaki Sauce Recalled for Botulism Risk

    Richard's Rub & Seasonings is recalling Too Good Teriyaki Sauce because it may be contaminated with Clostridium botulinum, which can cause botulism.

    Product
    Richards Too Good Teriyaki Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2234-2014·2014-08-06

    Richards Too Good Sauces Recalled for Potential Botulism Risk

    Richard's Rub & Seasonings is recalling three sauces due to improper processing and potential Clostridium botulinum contamination.

    Product
    Richards Too Good Hot Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1497-2014·2014-08-06

    Fagron Recalls Pentravan Base Due to Mold Contamination

    Fagron is recalling six lots of Pentravan Base 2.5 Kg due to the presence of mold. The product is used for prescription compounding.

    Product
    Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·050-2014·2014-08-06

    Cavanaugh Smoked Sausage Recalled for Undeclared Soy Allergen

    Zemco Industries is recalling Cavanaugh Smoked Sausage because it contains soy, a known allergen not listed on the label.

    Product
    New York Firm Recalls Sausage Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2237-2014·2014-08-06

    White Wave Recalls Silk Light Soymilk for Undeclared Almond

    White Wave Foods is recalling 20,442 half-gallon cartons of Silk Light Soymilk because the product may contain undeclared almondmilk.

    Product
    Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Colorado 80021, UPC 0 25293 60101 7
    Category
    Food
    Distribution
    17 states
  • SevereNHTSA·14V501000·2014-08-06

    Adrian Recalls 2012 Ford E-Series Vans Due to Propane Leak Risk

    Adrian Steel Company is recalling 28 model year 2012 Ford E-Series vans modified with propane kits. A metal reaction may cause a propane leak, increasing fire risk.

    Product
    FORD — FORD E-450, E-150, E-250, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2014·2014-08-06

    Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure

    Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.

    Product
    Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-2227-2014·2014-08-06

    Malt-O-Meal Frosted Flakes Bowls Recalled for Undeclared Honey and Oats

    mom Brands is recalling Malt-O-Meal Frosted Flakes foodservice bowls because they may contain undeclared honey and oats.

    Product
    Malt-O-Meal Frosted Flakes, item number 00955, UPC 42400-00955. Net Wt. 2.00oz (56g)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2236-2014·2014-08-06

    Plaze Bak-klene Bakery Spray Recalled for Undeclared Wheat

    Plaze Inc is recalling Professional Bak-klene All Purpose No-Stick Bakery Spray because it contains undeclared wheat.

    Product
    Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz. aerosol cans.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2112-2014·2014-08-06

    Wellspring Recalls IPM Wound Gel Rx Wound Dressing Due to Microbial Contamination

    Wellspring Pharmaceutical is recalling IPM Wound Gel Rx Wound Dressing due to a potential for microbial contamination. The product is distributed in the US and Canada.

    Product
    IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2123-2014·2014-08-06

    Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect

    Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.

    Product
    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2014·2014-08-06

    Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss

    Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.

    Product
    FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2014·2014-08-06

    Teleflex Recalls RUSCH TruLite Disposable Laryngoscope Handles

    Teleflex Medical is recalling RUSCH TruLite laryngoscope handles because the handle may heat up and melt the end cap.

    Product
    RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1498-2014·2014-08-06

    Fagron Recalls Pentravan Plus Base Due to Mold Contamination

    Fagron is recalling specific lots of Pentravan Plus Base, a prescription compounding ingredient, because of mold contamination.

    Product
    Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-fr
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1496-2014·2014-08-06

    Fagron Recalls Phytobase Cream Lots Due to Mold Contamination

    Fagron is recalling six lots of Phytobase Cream, a prescription compounding vehicle, due to the presence of mold.

    Product
    Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2014·2014-08-06

    Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment

    Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.

    Product
    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtro
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2238-2014·2014-08-06

    Whole Foods Caesar Salad Mini Recalled for Undeclared Allergens

    Whole Foods Market Group Inc. is recalling Caesar Salad Mini products due to switched labels that failed to declare tree nuts and fish.

    Product
    Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell
    Category
    Food
    Distribution
    3 states
  • HighCPSC·14251·2014-08-06

    Vizio Recalls 39- and 42-Inch E-Series Televisions Due to Tip-Over Risk

    Vizio is recalling about 245,000 39- and 42-inch E-Series televisions because the stand assembly can fail, causing the TV to tip over and pose an impact injury risk.

    Product
    VIZIO E-Series 39-inch and 42-inch televisions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2241-2014·2014-08-06

    King of Pops Banana Puddin' Recalled for Undeclared Soy and Wheat

    King of Pops is recalling Banana Puddin' pops due to undeclared soy and wheat allergens. Consumers with allergies should not consume the product.

    Product
    King of Pops Banana Puddin', frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2240-2014·2014-08-06

    King of Pops Key Lime Pie Recalled for Undeclared Soy and Wheat

    King of Pops is recalling Key Lime Pie frozen pops due to undeclared soy and wheat allergens. Consumers with allergies should not consume the product.

    Product
    King of Pops Key Lime Pie, frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·14V481000·2014-08-06

    Fiat 500L Recall: Driver Knee Airbag May Deploy Improperly

    Chrysler is recalling 2014-2015 Fiat 500L vehicles because the driver's knee airbag may not deploy correctly, increasing injury risk in a crash.

    Product
    FIAT — FIAT 500L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V485000·2014-08-06

    Newmar Recalls 2014 Dutch Star Motorhomes for Headlight Wiring Defect

    Newmar is recalling 2014 Dutch Star motorhomes because an incorrectly wired headlight harness may cause both headlights and fog lights to fail, increasing crash risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2014·2014-08-06

    Stryker InTouch Critical Care Bed Recall Due to Caster Failure

    Stryker is recalling InTouch Critical Care Beds because casters may break and fall off, potentially affecting brake functions.

    Product
    InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1488-2014·2014-08-06

    Dermamedics Calm & Correct Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Calm & Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2014·2014-08-06

    Dermamedics Serum Recalled for Lacking FDA Approval

    Dermamedics, L.L.C. is recalling Calm and Correct Serum because the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2014·2014-08-06

    Benicar HCT Tablets Recalled for Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 108 bottles of Benicar HCT 20 mg/12.5 mg tablets because they were not stored at controlled room temperature during shipping.

    Product
    Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1490-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling Dermamedics and Therametics Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2230-2014·2014-08-06

    Purefruit Chile Recalls Pouched Applesauce Due to Potential Mold

    Purefruit Chile S.A. is recalling fruty U applesauce pouches due to the possibility of mold. The product was distributed to retail stores nationwide.

    Product
    fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Ch
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1504-2014·2014-08-06

    Daiichi Sankyo Recalls Tribenzor Tablets Due to Temperature Abuse

    Daiichi Sankyo is recalling specific lots of Tribenzor tablets because they were not stored at controlled room temperature during shipping.

    Product
    Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2119-2014·2014-08-06

    Teleflex Medical Recalls Emerald Fiberoptic Blades Due to Packaging Error

    Teleflex Medical is recalling 120 units of Emerald Fiberoptic Blades because the boxes contained incorrect Miller 4 blades instead of the labeled Macintosh 4 blades.

    Product
    Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-1494-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling specific Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was dist
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1492-2014·2014-08-06

    Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2278-2014·2014-08-06

    GM Manufacturing Recalls Detoxification Plus Dietary Supplements

    GM Manufacturing is recalling Detoxification Plus dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Detoxification Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2249-2014·2014-08-06

    GM Manufacturing Recalls Affirm XL Blister Packs for cGMP Violations

    GM Manufacturing is recalling 4,000 units of Affirm XL dietary supplements in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Affirm XL, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2259-2014·2014-08-06

    GM Manufacturing Recalls Bitter Melon Supplements for cGMP Violations

    GM Manufacturing is recalling 380 units of Bitter Melon dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bitter Melon, 225cc HDPE Bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2242-2014·2014-08-06

    GM Manufacturing Recalls Tiger-X Blister Packs for cGMP Violations

    GM Manufacturing is recalling 11,218 units of Tiger-X dietary supplements in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Tiger-X, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2265-2014·2014-08-06

    GM Manufacturing Recalls BTI Lean Formula Dietary Supplements

    GM Manufacturing is recalling BTI Lean Formula dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    BTI Lean Formula, 400cc HDPE Bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2228-2014·2014-08-06

    Purefruit Chile Recalls Market Pantry Applesauce Pouches Due to Mold Risk

    Purefruit Chile S.A. is recalling Market Pantry applesauce pouches due to the possibility of mold. The product was distributed nationwide.

    Product
    Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2286-2014·2014-08-06

    GM Manufacturing Recalls Albert Capsules for cGMP Violations

    GM Manufacturing is recalling Albert Capsules dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Albert, Capsules
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2231-2014·2014-08-06

    Purefruit Chile Recalls Pouched Applesauce Due to Mold Possibility

    Purefruit Chile S.A. is recalling fruty U applesauce, apple cinnamon, due to the possibility of mold. The product was distributed to retail stores nationwide.

    Product
    fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE CINNAMON applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2269-2014·2014-08-06

    GM Manufacturing Recalls Actra-SX Vinyl Bags for cGMP Violations

    GM Manufacturing is recalling 188 units of Actra-SX Vinyl Bags distributed in California due to significant violations of dietary supplement cGMP regulations.

    Product
    Actra-SX, Vinyl Bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2281-2014·2014-08-06

    GM Manufacturing Recalls Bone & Joint Plus Dietary Supplements

    GM Manufacturing is recalling Bone & Joint Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bone & Joint Plus, Bottles
    Category
    Food
    Distribution
    1 state

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