The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
159
Severe
434
High
277
Moderate
532
Low
21

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 30% are Severe.

301–400 of 1423

  • ModerateFDA (Drugs)·D-881-2014·2014-01-29

    Cilostazol Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Cilostazol 100 mg tablets because they may have been mislabeled as Triamterene/Hydrochlorothiazide.

    Product
    CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185022360.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-941-2014·2014-01-29

    Aidapak Recalls Pyridoxine HCL Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 50 mg Pyridoxine HCL tablets because they may have been mislabeled as other medications. The affected products were distributed in four western states.

    Product
    PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440801.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-973-2014·2014-01-29

    Progesterone Capsules Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling 100 mg progesterone capsules that may have been mislabeled as ascorbic acid tablets.

    Product
    PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591396401.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1020-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling 500 mg Ascorbic Acid tablets that may have been mislabeled as Oxcarbazepine 150 mg.

    Product
    ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052380.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-913-2014·2014-01-29

    Aidapak Recalls Thyroid Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 30 mg Thyroid tablets because they may have been mislabeled as other prescription drugs.

    Product
    THYROID, Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456045801.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-768-2014·2014-01-29

    Aidapak Recalls Atomoxetine Capsules Due to Potential Label Mixup

    Aidapak Services is recalling 80 mg Atomoxetine capsules distributed in four states because they may be mislabeled as other medications.

    Product
    ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-929-2014·2014-01-29

    Aidapak Recalls Calcium and Cholecalciferol Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling specific lots of calcium/cholecalciferol/sodium tablets because they may have been mislabeled as other medications.

    Product
    CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536342408.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-985-2014·2014-01-29

    Methylprednisolone Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling methylprednisolone tablets that may have been mislabeled as omeprazole/sodium bicarbonate capsules.

    Product
    methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603459321.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-842-2014·2014-01-29

    Simvastatin Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Simvastatin 40 mg tablets because they may have been mislabeled as Metoprolol Tartrate 12.5 mg.

    Product
    SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715598.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-889-2014·2014-01-29

    Aidapak Recalls Chlorothalidone Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 50 mg Chlorothalidone tablets because they may have been mislabeled as Sennosides 8.6 mg tablets.

    Product
    CHLORTHALIDONE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378021301.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-963-2014·2014-01-29

    Aidapak Recalls Estropipate Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Estropipate 0.75 mg tablets because they may have been mislabeled as Mesalamine DR 400 mg capsules.

    Product
    ESTROPIPATE, Tablet, 0.75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591041401.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-846-2014·2014-01-29

    Venlafaxine Tablets Recalled Due to Potential Labeling Error

    Aidapak Services is recalling Venlafaxine HCL 75 mg tablets because they may have been mislabeled as Tacrolimus capsules.

    Product
    VENLAFAXINE HCL, Tablet, 75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-883-2014·2014-01-29

    Sodium Chloride Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 7,891 sodium chloride tablets that may have been mislabeled as other drugs due to a labeling error.

    Product
    SODIUM CHLORIDE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00223176001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-955-2014·2014-01-29

    Calcium Acetate Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Calcium Acetate tablets that may be mislabeled as Ascorbic Acid or Hyoscyamine Sulfate.

    Product
    CALCIUM ACETATE, Tablet, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00574011302.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-951-2014·2014-01-29

    Aidapak Recalls HydrOXYzine Pamoate Capsules Due to Labeling Mixup

    Aidapak Services, LLC is recalling 100 mg HydrOXYzine Pamoate capsules because they may have been mislabeled as other medications.

    Product
    hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-836-2014·2014-01-29

    Aidapak Recalls Disopyramide Phosphate Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Disopyramide Phosphate capsules because they may have been mislabeled as Thyroid tablets. The error could lead to patients receiving the wrong medication.

    Product
    DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093312901.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-825-2014·2014-01-29

    Aidapak Recalls Metoprolol Tartrate Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 50 mg metoprolol tartrate tablets because they may have been mislabeled as other medications.

    Product
    METOPROLOL TARTRATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093073301.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-777-2014·2014-01-29

    Carvedilol Phosphate ER Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Carvedilol Phosphate ER capsules due to a potential label mixup with Bumetanide tablets.

    Product
    CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00007337113.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-790-2014·2014-01-29

    Aidapak Recalls Lithium Carbonate ER Tablets Due to Labeling Errors

    Aidapak Services is recalling Lithium Carbonate ER tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1025-2014·2014-01-29

    Aidapak Recalls Aspirin EC Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Aspirin EC tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    ASPIRIN EC, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201360.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-806-2014·2014-01-29

    Aidapak Recalls Pregabalin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Pregabalin 200 mg capsules because they may have been mislabeled as other prescription drugs.

    Product
    PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101768.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0800-2014·2014-01-29

    Siemens ADVIA Chemistry Systems Recalled for Potential Result Misinterpretation

    Siemens is recalling ADVIA 1200 and 1650 chemistry systems because an overflow flag may cause users to misinterpret or edit test results.

    Product
    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-811-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Levothyroxine Sodium 175 mcg tablets because they may have been mislabeled as Cinacalcet HCl 60 mg.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1001-2014·2014-01-29

    Aidapak Recalls Isosorbide Dinitrate Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Isosorbide Dinitrate 5 mg tablets that may have been mislabeled as Cilostazol or Perphenazine.

    Product
    ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-983-2014·2014-01-29

    Aidapak Recalls Glycopyrrolate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1,300 tablets of Glycopyrrolate 2 mg because they may have been mislabeled as other prescription drugs.

    Product
    GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-964-2014·2014-01-29

    Aidapak Recalls Triamterene/Hydrochlorothiazide Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Triamterene/Hydrochlorothiazide tablets because they may have been mislabeled as Sevelamer HCl.

    Product
    TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591042401.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-860-2014·2014-01-29

    FDA Recalls Fenofibrate Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Fenofibrate 54 mg tablets that may have been mislabeled as Famciclovir 500 mg.

    Product
    FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-792-2014·2014-01-29

    Cilostazol Tablets Recalled for Potential Label Mixup with Calcium Acetate

    Aidapak Services is recalling Cilostazol 100 mg tablets due to a potential label mixup with Calcium Acetate capsules. The repacked drugs were distributed in four western states.

    Product
    CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054004421.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-814-2014·2014-01-29

    Fluvastatin Sodium Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Fluvastatin Sodium 20 mg capsules because they may be mislabeled as Valsartan 80 mg tablets.

    Product
    FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078017615.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0811-2014·2014-01-29

    Ziemer FEMTO LDV Z2, Z4, and Z6 Lasers Recalled for Monitor Overheating

    Ziemer USA Inc. is recalling five FEMTO LDV femtosecond surgical lasers because a controller board defect may cause the video monitor to overheat and shut off.

    Product
    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-802-2014·2014-01-29

    Aidapak Recalls Phenol Lozenges Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Phenol Lozenges because they may have been mislabeled as Atorvastatin Calcium or Vitamin B Complex W/C tablets.

    Product
    PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-788-2014·2014-01-29

    Aidapak Recalls Flecainide Acetate Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling Flecaainide Acetate tablets because they may be mislabeled as Colestipol HCL Micronized.

    Product
    FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-866-2014·2014-01-29

    Aidapak Recalls Methocarbamol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Methocarbamol 500 mg tablets because they may have been mislabeled as Losartan Potassium 25 mg.

    Product
    METHOCARBAMOL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143129001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-909-2014·2014-01-29

    Aidapak Recalls Fenofibrate Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling specific lots of Fenofibrate 54 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-812-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Levothyroxine Sodium tablets that may have been mislabeled as Multivitamin/Multimineral tablets.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074929690.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1017-2014·2014-01-29

    Aidapak Recalls Pyridoxine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 403 tablets of Pyridoxine HCL 50 mg because they may have been mislabeled as other medications. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052060.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-783-2014·2014-01-29

    Aidapak Recalls Pancrelipase DR Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Pancrelipase DR capsules because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-805-2014·2014-01-29

    Pregabalin Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Pregabalin 25 mg capsules because they may have been mislabeled as Cholecalciferol or Glyburide.

    Product
    PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101268.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-849-2014·2014-01-29

    Aidapak Recalls Irbesartan Tablets Due to Potential Labeling Error

    Aidapak Services is recalling 150 mg Irbesartan tablets because they may have been mislabeled as Benazepril HCl 40 mg.

    Product
    IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093746556.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1029-2014·2014-01-29

    Selenium Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 50 mcg selenium tablets that may be mislabeled as guaifenesin ER 600 mg.

    Product
    SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260.
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Devices)·Z-0801-2014·2014-01-29

    Philips CT Scanner Recall for Obscured Machine Name Label

    Philips is recalling 32 CT scanners because the machine name label is obscured in TumorLOC Basic Mode, preventing users from viewing or changing the name.

    Product
    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-747-2014·2014-01-29

    Teva Recalls Fluconazole Oral Suspension for Low Preservative Content

    Teva Pharmaceuticals is recalling Fluconazole Oral Suspension because the product has preservative levels below the required specification.

    Product
    Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0821-2014·2014-01-29

    Puritan Bennett Ventilator Manual Addendum Corrected for Oxygen Sensor Life

    Nellcor Puritan Bennett is correcting a labeling error in the PB840 Operator's Manual Addendum that incorrectly stated the oxygen sensor life as two years instead of one.

    Product
    Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V020000·2014-01-28

    Spartan MM Motorhome Chassis Recalled for Sway Bar End Link Defect

    Spartan Motors is recalling 2010-2014 MM motorhome chassis due to a front suspension design that may cause sway bar end links to break, increasing crash risk.

    Product
    SPARTAN — SPARTAN MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14091·2014-01-28

    Horizon Hobby Recalls Remote Controlled Model Helicopters Due to Injury Hazard

    Horizon Hobby is recalling specific Blade 500 model helicopters because the tail rotor grip can separate, posing a crash and injury risk.

    Product
    Blade 500 X BNF and Blade 500 3D RTF and BNF Remote Controlled Model Helicopters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V018000·2014-01-27

    Starcraft Transit Buses Recalled for Alternator Harness Pinch Risk

    Starcraft is recalling 2010-2013 transit buses because a pinched alternator harness could cause vehicle stalling or a fire.

    Product
    STARCRAFT — STARCRAFT STARQUEST, XPRESS, ULTRASTAR, STARLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V021000·2014-01-27

    Trails West RPM Trailers Recalled for Furnace Fire Risk

    Trails West is recalling 2010-2014 RPM trailers due to a furnace defect that may cause melting and fire.

    Product
    TRAILS WEST — TRAILS WEST RPM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V019000·2014-01-27

    Turtle Top Recalls Ford-Based Transit Buses Due to Electrical Fire Risk

    Turtle Top is recalling 453 Ford-based transit buses because a pinched alternator harness could cause a short circuit, fire, or vehicle stall.

    Product
    TURTLE TOP — TURTLE TOP FORD VAN TERRA, FORD LIMO COACH, FORD ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·007-2014·2014-01-27

    George's Recalls Frozen Chicken Products Due to Undeclared Wheat Allergen

    George's Inc. is recalling approximately 1.25 million pounds of frozen chicken products because wheat, a known allergen, was not declared on the labels.

    Product
    George's Further Processing — Arkansas Firm Recalls Frozen Chicken Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14V016000·2014-01-27

    Winnebago Recalls Trailers With Defective Door Locks That May Jam

    Winnebago is recalling specific 2011-2014 travel trailers and fifth wheels because a defect in the door lock may jam the deadbolt, potentially trapping occupants inside.

    Product
    SUNNYBROOK — SUNNYBROOK, WINNEBAGO BRISTOL BAY, BROOKSIDE, EDGEWATER, REMINGTON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V017000·2014-01-27

    Nu Wa Recalls 2011-2013 Hitchhiker Trailers Due to Door Lock Defect

    Nu Wa Industries is recalling 2011-2013 Hitchhiker fifth wheel trailers because a door lock defect may jam the deadbolt, trapping occupants inside.

    Product
    HITCHHIKER — HITCHHIKER LS, DISCOVER AMERICA, CHAMPAGNE EDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V014000·2014-01-24

    PACCAR Recalls 2012-2014 Kenworth and Peterbilt Trucks for Fire Risk

    PACCAR is recalling 2012-2014 Kenworth K300 and Peterbilt 210/220 trucks because a battery component may conduct electricity when hot, increasing fire risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 210, K300, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V013000·2014-01-24

    PACCAR Recalls Kenworth and Peterbilt Trucks for Seat Belt Defect

    PACCAR is recalling 2014 Kenworth and Peterbilt trucks because seat belt buckles may fail to release, hindering emergency egress.

    Product
    KENWORTH — KENWORTH, PETERBILT T880, T370, T660, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14090·2014-01-24

    Ergotron Recalls Interactive Wall Mounts Due to Weld Failure Risk

    Ergotron is recalling interactive wall mounts because a weld can fail, causing the TV to fall. No injuries have been reported, but property damage occurred.

    Product
    Ergotron Interactive Wall Mounts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V012000·2014-01-24

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Door Latch Defect

    PACCAR is recalling 2013-2014 Kenworth T680 and Peterbilt 567/579 trucks because door latches may lock permanently or fail to secure, trapping occupants in emergencies.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, 567, 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T001000·2014-01-23

    Lionshead Recalls 39,569 Vail Sport ST LH 99 Trailer Tires

    Lionshead Specialty Tire & Wheel LLC is recalling 39,569 Vail Sport ST LH 99 trailer tires because they may fail or unseat from rims, increasing crash risk.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14086·2014-01-23

    Matrix Fitness Ascent Trainers and Ellipticals Recalled Due to Fire Hazard

    Johnson Health Tech is recalling about 2,800 Matrix Fitness Ascent Trainers and Ellipticals sold to commercial facilities due to a fire hazard from moisture buildup in the power socket.

    Product
    Ascent Trainer® by Matrix and Matrix Fitness Elliptical
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V011000·2014-01-23

    Corn Pro Deckover Flatbed Trailer Recall for Tail Pivot Box Failure

    Cornelius Manufacturing is recalling 2012-2014 Corn Pro Deckover Flatbed Trailers because welded boxes allowing the tail to pivot may fail, increasing accident risk.

    Product
    CORN PRO — CORN PRO DECKOVER FLATBED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14089·2014-01-23

    Flushmate III Pressure-Assist Flushing System Recalled for Bursting Hazard

    Flushmate is recalling about 351,000 Flushmate III Pressure-Assist Flushing Systems sold in the U.S. because the units can burst, posing impact and laceration hazards.

    Product
    Flushmate® III Pressure-Assist Flushing System
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14712·2014-01-23

    Pottery Barn Recalls Morovian Star Pendant Chandeliers Due to Injury Risk

    Pottery Barn is recalling approximately 1,100 Morovian Star Pendant Chandeliers because the joints may fail, causing the fixture to fall. No injuries have been reported.

    Product
    Oversized Morovian Star Pendant Chandeliers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14088·2014-01-23

    Suunto Recalls Scuba Air Hoses Due To Drowning Hazard

    Suunto is recalling about 1,300 scuba high-pressure air hoses sold in the U.S. because they may leak or rupture, causing a loss of breathing gas and posing a drowning hazard.

    Product
    Scuba high-pressure air hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14087·2014-01-23

    Rayovac Flashlights Recalled by Spectrum Brands Due to Burn Hazard

    Spectrum Brands is recalling specific Rayovac LED flashlights because they can overheat and melt, posing a burn hazard. No injuries have been reported.

    Product
    Rayovac flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1375-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GREEN APPLE Manufactured for USPlabs, LLC (Dallas, TX 75220)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1371-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro dietary supplements containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1427-2014·2014-01-22

    Del Campo Dried Potato Recall Due to Undeclared Sulfites

    Megabusiness LLC is recalling Del Campo Papa Seca dried potatoes because the product contains undeclared sulfites. The recall covers 39.5 cases distributed in New York, New Jersey, Connecticut, and Illinois.

    Product
    DEL CAMPO PAPA SECA DRIED POTATO NET WT 14 OZ IMPORTED BY MEGABUSINESS PRODUCT OF PERU. UPC CODE 891726000218
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1374-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs, LLC is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1372-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Risk

    USPlabs is recalling OxyELITE Pro Super Thermo Powder Plus Advanced Carnitine Transport System because it contains Aegeline, which is associated with serious liver damage or acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1373-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Linked to Liver Damage

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1370-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Super Thermo Due to Liver Damage Risk

    USPlabs is recalling OxyELITE Pro Super Thermo dietary supplements containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-461-2014·2014-01-22

    Hospira Recalls Aminosyn II Amino Acid Injection Due to Particulate Matter

    Hospira is recalling 17,256 containers of Aminosyn II 10% Amino Acid Injection because a human hair was found in the injection port.

    Product
    Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1376-2014·2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) RASPBERRY LEMONADE Manufactured for USPlabs, LLC (Dallas, TX 75220)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-649-2014·2014-01-22

    FDA Recalls Misoprostol Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Misoprostol 200 mcg tablets because they may be mislabeled as Propranolol HCl or Sodium Chloride.

    Product
    MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-626-2014·2014-01-22

    Aidapak Recalls Tramadol Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 25 mg Tramadol HCl tablets that may be mislabeled as Levothyroxine Sodium 137 mcg.

    Product
    traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664037708
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-701-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Cholecalciferol/Calcium/Phosphorus tablets because they may be mislabeled as Promethazine HCl or Valsartan.

    Product
    CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-428-2014·2014-01-22

    Lidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-646-2014·2014-01-22

    Mirtazapine Tablets Recalled for Potential Mislabeling as Isoniazid

    Aidapak Services is recalling Mirtazapine 7.5 mg tablets that may be mislabeled as Isoniazid 300 mg. The error poses a risk of incorrect medication administration.

    Product
    MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141509
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1416-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Fish Products Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Variety Smoked Pack is sold in vacuum packed plastic packages, net weight 1.5 lbs., with label located on the front that include the pack date and AK 604. No label was provided.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-452-2014·2014-01-22

    Tropicamide 1% Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Tropicamide 1% Ophthalmic Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0714-2014·2014-01-22

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.

    Product
    Draeger Infinity Acute Care System Monitoring Solution
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-458-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls 0.9% Sodium Chloride Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.

    Product
    0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-410-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Acetylcysteine Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1389-2014·2014-01-22

    Jensen's Recalls Hot Smoked Halibut Due to Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Hot Smoked Halibut because it may lack 'KEEP FROZEN' labeling and could be contaminated with Clostridium botulinum.

    Product
    Low salt, vacuum packaged, Hot Smoked Halibut was sold under brand Clippership. No product labeling was provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0726-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1402-2014·2014-01-22

    Josephson's Hot Smoked Pepper Atlantic Salmon Recalled for Botulism Risk

    Josephson's Smokehouse is recalling hot smoked pepper Atlantic salmon because the products were undercooked, posing a potential hazard of Clostridium botulinum toxin formation.

    Product
    Hot Smoked Pepper Atlantic Salmon, Item HS-C, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for net weight 0.425 lbs. is 0 240120 813603. The label is read in part: HOT SMOKED PEPPERED ATLANTIC…
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-529-2014·2014-01-22

    FDA Recalls Mislabeling of Propranolol HCL Tablets

    Aidapak Services is recalling 2,299 Propranolol HCL 10 mg tablets due to potential mislabeling as other medications.

    Product
    PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-433-2014·2014-01-22

    Naloxone Injectable Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-644-2014·2014-01-22

    Aidapak Recalls Nifedipine Capsules Due to Potential Labeling Error

    Aidapak Services is recalling Nifedipine 10 mg capsules because they may be mislabeled as Nitrofurantoin 100 mg. The repacked drugs were distributed in four western states.

    Product
    NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0743-2014·2014-01-22

    Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-608-2014·2014-01-22

    FDA Recalls FIDAXOMICIN Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling FIDAXOMICIN 200 mg tablets that may be mislabeled as BENAZEPRIL HCL 40 mg. The error affects repacked drugs distributed in four western states.

    Product
    FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1421-2014·2014-01-22

    Glass Onion Catering Recalls Trader Joe's Greek Salad Due to E. coli Outbreak

    Glass Onion Catering is recalling Trader Joe's Classic Greek Salad because an investigation linked the supplier to an E. coli O157:H7 outbreak.

    Product
    Trader Joe's Classic Greek Salad with Feta Cheese, Cucumber Kalamata olives and Greek Dressing; (9 oz) (255 g) in plastic clam shell container. Packaged for Trader Joe's Manufactured by Glass Onion Catering, Richmond, CA
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-438-2014·2014-01-22

    Phenol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.

    Product
    Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state

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