The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
161
Severe
415
High
291
Moderate
533
Low
23

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

1–100 of 1423

  • CriticalUSDA FSIS·008-2014·2014-01-30

    Walker's Recalls Chicken Salad Products Due to Undeclared Soy Allergen

    Walker's Food Products is recalling chicken salad products because they contain soy protein concentrate, a known allergen, that was not declared on the labels.

    Product
    Walker's Food Products Co. — Missouri Firm Recalls Chicken Salad Products Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereCPSC·14095·2014-01-30

    Gree Recalls GE Brand Dehumidifiers Due to Fire and Burn Hazards

    Gree is expanding its recall to include GE-brand dehumidifiers that can overheat, smoke, and catch fire. Consumers should unplug the units and contact Gree for a refund.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V026000·2014-01-30

    Kenworth T370 Recall for Transmission Software Defect

    PACCAR is recalling 2014 Kenworth T370 chassis with Eaton hybrid transmissions because software may cause unintended acceleration.

    Product
    KENWORTH — KENWORTH T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14098·2014-01-30

    Britax Recalls Strollers Due to Fingertip Amputation Hazard

    Britax is recalling B-Agile and BOB Motion strollers because the folding mechanism can amputate fingertips or break fingers.

    Product
    B-Agile, B-Agile Double and BOB Motion strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14097·2014-01-30

    Fred & Friends Recalls Infant Pacifiers Due to Choking Hazard

    Fred & Friends is recalling Chill Baby Artiste, Volume, and Panic pacifiers because parts can detach and pose a choking hazard to young children.

    Product
    Fred & Friends Chill Baby Artiste, Volume and Panic pacifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1437-2014·2014-01-29

    Flat Creek Farm Recalls Raw Milk Blue Cheese Due to Salmonella

    Flat Creek Farm & Dairy is recalling Heavenly Blue raw milk cheese contaminated with Salmonella. The product was distributed in Alabama, Florida, Georgia, and Tennessee.

    Product
    Heavenly Blue, (Raw milk, salt, culture, coagulant ), Flat Creek Lodge, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401. The raw milk blue cheese is packaged in clear plastic, with sizes ranging from 1/2 lb to whole wheels.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-861-2014·2014-01-29

    Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup

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

    Product
    DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-796-2014·2014-01-29

    Buprenorphine HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Buprenorphine HCL SL tablets due to a potential label mixup with other medications.

    Product
    BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-873-2014·2014-01-29

    Dutasteride Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 0.5 mg dutasteride capsules because they may have been mislabeled as phenol, repaglinide, or cholecalciferol.

    Product
    DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071215.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1033-2014·2014-01-29

    Hospira Recalls Propofol Vials Due to Glass Particulate Matter

    Hospira is recalling 126,425 vials of Propofol Injectable Emulsion due to a glass defect that could release particulate matter into the solution.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-898-2014·2014-01-29

    Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1024-2014·2014-01-29

    Aidapak Recalls Niacin TR Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Niacin TR capsules because they may have been mislabeled as other drugs like Perphenazine or Melatonin.

    Product
    NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-892-2014·2014-01-29

    Thioridazine HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Thioridazine HCL 50 mg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.

    Product
    THIORIDAZINE HCL, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378061601.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-867-2014·2014-01-29

    Aidapak Recalls Doxycycline Hyclate Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Doxycycline Hyclate 100 mg capsules because they may have been mislabeled as Raloxifene HCL 60 mg tablets.

    Product
    DOXYCYCLINE HYCLATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143314250.
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·14V027000·2014-01-29

    Kenworth T660 and T680 Recalled for Incorrect Parking Brake Placement

    PACCAR is recalling 2013-2014 Kenworth T660 and T680 trucks because the parking brake is incorrectly placed on the non-driven rear axle, increasing the risk of the vehicle rolling away.

    Product
    KENWORTH — KENWORTH T660, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-824-2014·2014-01-29

    FDA Recalls Diltiazem Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Diltiazem HCL 120 mg tablets that may have been mislabeled as Nicotine Polacrilex 2 mg lozenges.

    Product
    DILTIAZEM HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093032101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0780-2014·2014-01-29

    Elekta XiO RTP System Recalled for Dose Calculation Error

    Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.

    Product
    XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional rad
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-893-2014·2014-01-29

    FDA Recalls Tizanidine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Tizanidine HCl 2 mg tablets that may have been mislabeled as Niacin TR 500 mg.

    Product
    tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1014-2014·2014-01-29

    FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acamprosate calcium. The error could lead to patients receiving the wrong medication.

    Product
    chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030200.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-938-2014·2014-01-29

    Aidapak Recalls Multivitamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling multivitamin tablets that may have been mislabeled as sitagliptin or loratadine. The FDA classifies this as a Class II recall.

    Product
    MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536406001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-959-2014·2014-01-29

    FDA Recalls Hyoscyamine Sulfate Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling 909 tablets of Hyoscyamine Sulfate SL 0.125 mg because they may have been mislabeled as other prescription drugs.

    Product
    HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-870-2014·2014-01-29

    Aidapak Recalls Anagrelide HCL Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Anagrelide HCL capsules because they may have been mislabeled as Aripiprazole tablets.

    Product
    ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172524160.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-839-2014·2014-01-29

    Aidapak Recalls Escitalopram Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 5 mg Escitalopram tablets because they may have been mislabeled as Sodium Chloride tablets.

    Product
    ESCITALOPRAM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093585001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0812-2014·2014-01-29

    Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

    Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

    Product
    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-978-2014·2014-01-29

    Aidapak Recalls Minocycline Capsules Due to Potential Labeling Error

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

    Product
    MINOCYCLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569401.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-960-2014·2014-01-29

    Aidapak Recalls Lorazepam Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lorazepam tablets that may have been mislabeled as Tramadol HCl. The repacked drugs were distributed in four western states.

    Product
    LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591024001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-779-2014·2014-01-29

    FDA Recalls Potentially Mislabeled Sirolimus Tablets Distributed by Aidapak Services

    Aidapak Services is recalling 1 mg Sirolimus tablets that may be mislabeled as Propranolol or Hydrocortisone. The repacked drugs were distributed in four western states.

    Product
    SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-923-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Levothyroxine Sodium 175 mcg tablets because they may have been mislabeled as other medications.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-856-2014·2014-01-29

    FDA Recalls Mislabeled Mexiletine HCL Capsules Distributed by Aidapak Services

    Aidapak Services, LLC is recalling 200 mg Mexiletine HCL capsules that may have been mislabeled as 10 mg Isosorbide Dinitrate tablets.

    Product
    MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093874001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1034-2014·2014-01-29

    Fresenius Kabi Recalls Tranexamic Acid Injection Due to Particulate Matter

    Fresenius Kabi USA is recalling 121,456 vials of Tranexamic Acid Injection USP due to the presence of particulate matter consistent with glass vial delamination.

    Product
    Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-832-2014·2014-01-29

    FDA Recalls Sotalol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Sotalol HCL 120 mg tablets because they may have been mislabeled as Neomycin Sulfate 500 mg tablets.

    Product
    SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-979-2014·2014-01-29

    Aidapak Recalls Minocycline Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Minocycline HCL capsules that may have been mislabeled as Progesterone. The repacked drugs were distributed in four western states.

    Product
    MINOCYCLINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569550.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-841-2014·2014-01-29

    Simvastatin Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Simvastatin 5 mg tablets that may be mislabeled as Losartan Potassium 25 mg.

    Product
    SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715298.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-977-2014·2014-01-29

    Minoxidil Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Minoxidil 2.5 mg tablets because they may have been mislabeled as methylprednisolone 4 mg.

    Product
    MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591564201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-954-2014·2014-01-29

    FDA Recalls Bromocriptine Mesylate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2.5 mg Bromocriptine Mesylate tablets because they may have been mislabeled as Benazepril HCl or Thioridazine HCl.

    Product
    BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010603.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-982-2014·2014-01-29

    FDA Recalls Mislabeled Acetaminophen, Butalbital, and Caffeine Tablets

    Aidapak Services, LLC is recalling Acetaminophen/Butalbital/Caffeine tablets that may have been mislabeled as Aspirin. The error could cause patients to take the wrong medication.

    Product
    ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603254421.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-989-2014·2014-01-29

    Aidapak Recalls Perphenazine Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Perphenazine 16 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-961-2014·2014-01-29

    Aidapak Recalls Loxapine Capsules Due to Potential Sertraline Labeling Error

    Aidapak Services, LLC is recalling Loxapine 5 mg capsules that may have been mislabeled as Sertraline HCL 50 mg tablets. The repacked drugs were distributed in four western states.

    Product
    LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-919-2014·2014-01-29

    Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Digoxin 125 mcg tablets because they may have been mislabeled as Cholecalciferol/Calcium/Phosphorus tablets.

    Product
    DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-859-2014·2014-01-29

    Terbutaline Sulfate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Terbutaline Sulfate 2.5 mg tablets because they may have been mislabeled as Sotalol HCl 80 mg.

    Product
    TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-800-2014·2014-01-29

    FDA Recalls Efavirenz Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Efavirenz 200 mg capsules because they may have been mislabeled as metformin HCl 500 mg tablets.

    Product
    EFAVIRENZ, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00056047492.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-952-2014·2014-01-29

    FDA Recalls Estradiol Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Estradiol 0.5 mg tablets because they may have been mislabeled as Nicotine Polacrilex gum.

    Product
    ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555089902.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1022-2014·2014-01-29

    Aidapak Recalls Thiamine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Thiamine HCL 100 mg tablets because they may have been mislabeled as other drugs, including simvastatin and buprenorphine.

    Product
    THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904054460.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-937-2014·2014-01-29

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services is recalling 18,282 Cholecalciferol capsules because they may have been mislabeled as other drugs, including Doxycycline and Lamotrigine.

    Product
    CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-764-2014·2014-01-29

    Cubicin Injection Recalled for Glass Particulates in Vials

    Cubist Pharmaceuticals is recalling 179,870 vials of Cubicin (daptomycin for injection) due to the presence of glass particulates.

    Product
    Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-887-2014·2014-01-29

    Aidapak Recalls Rosuvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling 5 mg rosuvastatin calcium tablets because they may have been mislabeled as ibuprofen or ascorbic acid.

    Product
    ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-944-2014·2014-01-29

    Aidapak Recalls Niacin TR Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Niacin TR 750 mg tablets because they may have been mislabeled as Nortriptyline HCL 50 mg capsules.

    Product
    NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703301.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-895-2014·2014-01-29

    Aidapak Recalls Guanfacine HC Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Guanfacine HC tablets because they may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-998-2014·2014-01-29

    FDA Recalls Perphenazine Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 16 mg Perphenazine tablets because they may have been mislabeled as other prescription drugs.

    Product
    PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781104901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-981-2014·2014-01-29

    FDA Recalls Bismuth Subsalicylate Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Bismuth Subsalicylate chewable tablets that may have been mislabeled as Irbesartan. The error could lead to patients taking the wrong medication.

    Product
    BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1008-2014·2014-01-29

    Aidapak Recalls Mislabeled Methylprednisolone Tablets

    Aidapak Services, LLC is recalling methylprednisolone tablets that may have been mislabeled as levothyroxine, nabumetone, or cholecalciferol.

    Product
    methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0788-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-826-2014·2014-01-29

    FDA Recalls Piroxicam Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 10 mg Piroxicam capsules because they may have been mislabeled as Hyoscyamine Sulfate. The error could lead to patients receiving the wrong medication.

    Product
    PIROXICAM, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093075601.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-795-2014·2014-01-29

    Aidapak Recalls Acarbose Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Acarbose 25 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-947-2014·2014-01-29

    FDA Recalls Vitamin B Complex Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Vitamin B Complex tablets that may have been mislabeled as Cinacalcet HCl. The repacked drugs were distributed in four western states.

    Product
    VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536730001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-855-2014·2014-01-29

    FDA Recalls MEXILETINE HCL Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling MEXILETINE HCL capsules because they may have been mislabeled as CALCIUM ACETATE. The error could lead to patients receiving the wrong medication.

    Product
    MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-827-2014·2014-01-29

    Aidapak Recalls Nortriptyline Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 10 mg Nortriptyline HCL capsules because they may have been mislabeled as 80 mg Valsartan tablets.

    Product
    NORTRIPTYLINE HCL, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1006-2014·2014-01-29

    Tacrolimus Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 0.5 mg tacrolimus capsules because they may have been mislabeled as cinacalcet or isosorbide mononitrate.

    Product
    TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-992-2014·2014-01-29

    FDA Recalls Phenobarbital Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Phenobarbital tablets that may have been mislabeled as Efavirenz capsules. The error involves a label mixup during repacking.

    Product
    PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-850-2014·2014-01-29

    Aidapak Recalls Glyburide Tablets Due to Potential Label Mixup

    Aidapak Services is recalling glyBURIDE MICRONIZED tablets because they may have been mislabeled as digoxin. The error could lead to patients receiving the wrong medication.

    Product
    glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093803501.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-928-2014·2014-01-29

    Aidapak Recalls Aspirin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 325 mg aspirin tablets because they may have been mislabeled as other prescription medications.

    Product
    ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536330501.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1026-2014·2014-01-29

    Aidapak Recalls Tri-Buffered Aspirin Tablets Due to Labeling Error

    Aidapak Services is recalling Tri-Buffered Aspirin tablets because they may have been mislabeled as a different medication. The error involves a potential mix-up with Isometheptene Mucate/Dichlorphenazone/APAP capsules.

    Product
    TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1031-2014·2014-01-29

    KVK-Tech Recalls Hydroxyzine Hydrochloride Tablets Due to Unapproved Ingredient Source

    KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride tablets because the active pharmaceutical ingredient was sourced from an unapproved supplier.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-900-2014·2014-01-29

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Atorvastatin Calcium 10 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-903-2014·2014-01-29

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 80 mg Atorvastatin Calcium tablets because they may have been mislabeled as other prescription drugs.

    Product
    ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-755-2014·2014-01-29

    Novartis Recalls Theraflu Flu and Chest Congestion Powder Packets

    Novartis Consumer Health is recalling Theraflu Flu & Chest Congestion powder packets because they may contain foreign substances.

    Product
    Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-879-2014·2014-01-29

    Aidapak Recalls Lovastatin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 20 mg Lovastatin tablets because they may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185007201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-897-2014·2014-01-29

    Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as other prescription drugs.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-765-2014·2014-01-29

    Aidapak Recalls Atomoxetine Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as other psychiatric medications.

    Product
    ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-844-2014·2014-01-29

    Losartan Potassium Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Losartan Potassium 25 mg tablets because they may have been mislabeled as Phytonadione 5 mg.

    Product
    LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093736498.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-854-2014·2014-01-29

    Aidapak Recalls Mislabeled glyBURIDE Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling glyBURIDE tablets that may have been mislabeled as other prescription drugs. The error poses a risk of patients receiving incorrect medication.

    Product
    glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-990-2014·2014-01-29

    FDA Recalls Phenobarbital Tablets Due to Potential Pregabalin Labeling Error

    Aidapak Services is recalling Phenobarbital tablets that may be mislabeled as Pregabalin capsules. The error poses a risk of patients receiving the wrong medication.

    Product
    PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-815-2014·2014-01-29

    FDA Recalls Valsartan Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Valsartan 80 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-847-2014·2014-01-29

    Venlafaxine HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Venlafaxine HCL 100 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738301.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-820-2014·2014-01-29

    Carbamazepine ER Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as isosorbide dinitrate or sirolimus.

    Product
    carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078051005.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-993-2014·2014-01-29

    FDA Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.

    Product
    PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-786-2014·2014-01-29

    FDA Recalls Repacked Progesterone Capsules Due to Potential Labeling Error

    Aidapak Services is recalling repacked progesterone capsules that may be mislabeled as levothyroxine sodium tablets. The error could lead to patients receiving the wrong medication.

    Product
    PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032170801.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1018-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 250 mg Ascorbic Acid tablets because they may have been mislabeled as other prescription or over-the-counter drugs.

    Product
    ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052260.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-940-2014·2014-01-29

    Aidapak Recalls Pyridoxine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 25 mg tablets because they may have been mislabeled as Torsemide 10 mg.

    Product
    PYRIDOXINE HCL, Tablet, 25 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440601.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-975-2014·2014-01-29

    FDA Recalls Mislabeled Quinidine Sulfate Tablets Distributed by Aidapak

    Aidapak Services, LLC is recalling Quinidine Sulfate 200 mg tablets that may have been mislabeled as Quinapril 40 mg. The error occurred during repacking in four western states.

    Product
    quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591543801.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1019-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 500 mg Ascorbic Acid tablets because they may have been mislabeled as Venlafaxine HCL 100 mg.

    Product
    ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052372.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0796-2014·2014-01-29

    Carestream DRX-Evolution X-Ray Systems Recalled for Unexpected Movement

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 systems due to a risk of unexpected device movement.

    Product
    DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray tab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2014·2014-01-29

    Philips Recalls ADAC Gamma Camera Systems Due to Fork Joint Crack Risk

    Philips Medical Systems is recalling ADAC ARGUS and CIRRUS Gamma Camera Systems because routine maintenance may fail to detect small cracks in the fork weldments.

    Product
    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2014·2014-01-29

    Radiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias

    Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium results.

    Product
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Drugs)·D-748-2014·2014-01-29

    Novartis Recalls Theraflu Flu and Sore Throat Powder Packets

    Novartis is recalling Theraflu Flu & Sore Throat powder packets because they may contain foreign substances. The recall affects 1.6 million cartons distributed in the US and internationally.

    Product
    Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-957-2014·2014-01-29

    Liothyronine Sodium Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Liothyronine Sodium 25 mcg tablets because they may have been mislabeled as Levothyroxine Sodium or Hyoscyamine Sulfate.

    Product
    LIOTHYRONINE SODIUM, Tablet, 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574022201.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-756-2014·2014-01-29

    Theraflu Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances

    Novartis Consumer Health is recalling Theraflu Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.

    Product
    Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2014·2014-01-29

    Siemens Recalls SimView NT Radiation Therapy Simulation Systems

    Siemens is recalling 65 SimView NT radiation therapy simulation systems worldwide because a rare mechanical failure could prevent the stopping of intended component movements.

    Product
    SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-999-2014·2014-01-29

    Methazolamide Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Methazolamide tablets that may have been mislabeled as Buprenorphine HCL due to a label mixup.

    Product
    METHAZOLAMIDE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781107101.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-770-2014·2014-01-29

    Entecavir Tablets Recalled Due to Potential Label Mixup

    Aidapak Services is recalling Entecavir tablets because they may be mislabeled as other prescription drugs.

    Product
    ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00003161112.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-758-2014·2014-01-29

    Novartis Recalls NeoCitran Powder Packets Due to Foreign Substances

    Novartis Consumer Health is recalling specific lots of NeoCitran powder packets because they may contain foreign substances. The products were distributed in the US, Canada, Mexico, and other countries.

    Product
    NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2014·2014-01-29

    GE Healthcare Patient Data Module Recall for ECG Noise

    GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-751-2014·2014-01-29

    Novartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence

    Novartis is recalling Theraflu and related cold medicine powder packets because they may contain foreign substances. The recall affects products distributed in the US, Canada, Mexico, and other countries.

    Product
    Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 006
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-921-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134401.
    Category
    Drug
    Distribution
    4 states

Looking for a different month? Back to 2014.