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.

101–200 of 1423

  • HighFDA (Devices)·Z-0805-2014·2014-01-29

    Sorin Orchestra Programmer Overestimates Pacemaker Battery Life

    Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.

    Product
    ORCHESTRA/ORCHESTRA PLUS Programmer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-787-2014·2014-01-29

    Aidapak Recalls Calcitriol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Calcitriol 0.25 mcg capsules because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054000725.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0813-2014·2014-01-29

    Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking

    Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.

    Product
    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

    Product
    DRX-Evolution with CSH 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 ta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2014·2014-01-29

    Ranir Recalls TopCare and Up & Up Kids Power Toothbrushes

    Ranir is recalling TopCare and Up & Up kids' power toothbrushes because the tufted disk may detach, posing a choking hazard to children three and younger.

    Product
    TopCare Clifford THE BIG RED DOG power toothbrush for kids!
    Category
    Consumer Product
    Distribution
    2 states
  • HighFDA (Devices)·Z-0808-2014·2014-01-29

    GE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise

    GE Healthcare is recalling 1,948 TRAM Modules because movement of the ECG cable connector causes intermittent noise on ECG and respiration waveforms, potentially reducing monitoring performance.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2014·2014-01-29

    GE Healthcare Recalls Dash Patient Monitors Due to ECG Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because cable movement causes intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2014·2014-01-29

    Ranir Recalls UP & UP Kids' Power Toothbrushes Due to Choking Hazard

    Ranir is recalling UP & UP and TopCare kids' power toothbrushes because the tufted disk may detach, posing a choking hazard to children three and younger.

    Product
    UP & UP kids' power toothbrush
    Category
    Consumer Product
    Distribution
    2 states
  • HighFDA (Devices)·Z-0823-2014·2014-01-29

    Siemens CentraLink Software Recall for Potential Patient Data Release Error

    Siemens is recalling CentraLink Data Management System software versions 14.0.4, 14.0.5, and 14.0.8 because a disabled patient result may be released without proper review.

    Product
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data fro
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0809-2014·2014-01-29

    CryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns

    CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.

    Product
    Pulmonary Hemi-Artery SG Used in heart surgery
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Devices)·Z-0798-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 diagnostic x-ray systems due to a potential for unexpected device movement.

    Product
    DR 7500 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 table and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2014·2014-01-29

    Medrad Recalls Veris MR Monitor Units Due to Faulty Main Board

    Medrad is recalling 922 Veris MR Monitor units because a faulty main board may cause unexpected system shutdowns, resulting in the loss of vital signs information.

    Product
    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas mo
    Category
    Medical Device
    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 (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 (Devices)·Z-0787-2014·2014-01-29

    Siemens Linac Treatment Table Recall for Finger Pinch and Cable Damage

    Siemens is recalling 305 linear accelerator treatment tables due to risks of finger pinching and cable short-circuits.

    Product
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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-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-875-2014·2014-01-29

    Aidapak Recalls Aspirin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 81 mg Aspirin DR EC tablets because they may have been mislabeled as Sotalol HCl or Folic Acid.

    Product
    ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182106105.
    Category
    Drug
    Distribution
    4 states
  • 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 (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 (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
  • ModerateFDA (Drugs)·D-882-2014·2014-01-29

    Aidapak Recalls Candesartan Cilexetil Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Candesartan Cilexetil 16 mg tablets because they may have been mislabeled as Irbesartan 150 mg.

    Product
    CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00186001631.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-920-2014·2014-01-29

    Aidapak Recalls Levothyroxine Sodium Tablets Due to Potential Label Mixup

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

    Product
    LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-915-2014·2014-01-29

    Aidapak Recalls Nebivolol Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Nebivolol HCL 5 mg tablets because they may have been mislabeled as Thyroid or Rasagiline Mesylate.

    Product
    NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.
    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-970-2014·2014-01-29

    Aidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Nifedipine ER 60 mg tablets because they may have been mislabeled as Nicotine Polacrilex 2 mg lozenges.

    Product
    NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591319401.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-914-2014·2014-01-29

    Aidapak Recalls Thyroid Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 60 mg Thyroid tablets that may have been mislabeled as 30 mg tablets.

    Product
    THYROID, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456045901.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-778-2014·2014-01-29

    Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets

    Aidapak Services is recalling 20 mg Pantoprazole Sodium DR tablets because they may be mislabeled as Hyoscyamine Sulfate or Multivitamin/Multimineral.

    Product
    PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-924-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Levothyroxine Sodium tablets that may have been mislabeled as Isoniazid due to a labeling error.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527163801.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-750-2014·2014-01-29

    Novartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances

    Novartis Consumer Health is recalling Theraflu Severe Cold & Cough powder packets because they may contain foreign substances. The recall covers 917,400 cartons distributed in the US and internationally.

    Product
    Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine h
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1016-2014·2014-01-29

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Vitamin B Complex tablets because they may have been mislabeled as other drugs. The repacked products were distributed in four western states.

    Product
    VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904026013.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-809-2014·2014-01-29

    Aidapak Recalls Paricalcitol Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Paricalcitol capsules because they may have been mislabeled as Ascorbic Acid or Cholecalciferol.

    Product
    PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074431730.
    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-1028-2014·2014-01-29

    Aidapak Recalls Niacin Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Niacin 500 mg tablets because they may have been mislabeled as Naproxen or Docusate Sodium.

    Product
    NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227260.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-962-2014·2014-01-29

    Verapamil Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Verapamil HCL tablets because they may have been mislabeled as Atorvastatin or Tacrolimus.

    Product
    VERAPAMIL HCL, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591040401.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1015-2014·2014-01-29

    FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acyclovir or trimethobenzamide. The error occurred during repacking in four western states.

    Product
    chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030300.
    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-749-2014·2014-01-29

    Novartis Recalls Theraflu Cold and Cough Powder Packets

    Novartis is recalling Theraflu Daytime Severe Cold & Cough powder packets and NeoCitran products due to the potential presence of foreign substances.

    Product
    Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsip
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-746-2014·2014-01-29

    Greenstone Recalls Sertraline Tablets Due to Incorrect Expiration Date Labeling

    Greenstone LLC is recalling 585,096 bottles of sertraline HCl tablets because the expiration dates reflect a 36-month shelf life instead of the correct 24-month shelf life.

    Product
    sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-775-2014·2014-01-29

    Aidapak Recalls Raltegravir Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Raltegravir 400 mg tablets because they may be mislabeled as other medications. The recall covers specific lots distributed in four western states.

    Product
    RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-931-2014·2014-01-29

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 100 mcg cyanocobalamin tablets because they may have been mislabeled as guaiFENesin ER 600 mg tablets.

    Product
    CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536354201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-991-2014·2014-01-29

    Aidapak Recalls Phenobarbital Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Phenobarbital 97.2 mg tablets because they may have been mislabeled as 64.8 mg tablets.

    Product
    PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
    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-910-2014·2014-01-29

    Fluvastatin Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Fluvastatin 20 mg capsules because they may have been mislabeled as a different medication.

    Product
    FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378802077.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1021-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Ascorbic Acid chew tablets because they may have been mislabeled as Phenol lozenges.

    Product
    ASCORBIC ACID, CHEW Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052660.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-922-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as Raltegravir 400 mg.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.
    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-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-823-2014·2014-01-29

    Carbidopa/Levodopa Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Carbidopa/Levodopa tablets that may have been mislabeled as Digoxin. Patients should verify their medication labels.

    Product
    CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093029401.
    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-794-2014·2014-01-29

    FDA Recalls Calcium Acetate Capsules Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Calcium Acetate capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.
    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-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-888-2014·2014-01-29

    Metoprolol Tartrate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may have been mislabeled as Docusate Sodium 250 mg capsules.

    Product
    METOPROLOL TARTRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378001801.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-830-2014·2014-01-29

    Aidapak Recalls Clonazepam Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling clonazepam 0.25 mg tablets that may have been mislabeled as cholecalciferol 2000 units capsules.

    Product
    clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00093083201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-851-2014·2014-01-29

    FDA Recalls Famciclovir Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Famciclovir 500 mg tablets because they may have been mislabeled as Tolterodine or Thiamine.

    Product
    FAMCICLOVIR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093811956.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-772-2014·2014-01-29

    Aidapak Recalls Mycophenolate Mofetil Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling 500 mg Mycophenolate Mofetil tablets because they may be mislabeled as 250 mg capsules.

    Product
    MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004026001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-874-2014·2014-01-29

    Omega-3 Acid Ethyl Esters Capsules Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Omega-3 Acid Ethyl Esters capsules due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.

    Product
    OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-939-2014·2014-01-29

    FDA Recalls Calcium Polycarbophil Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Calcium Polycarbophil tablets that may be mislabeled as Caffeine tablets. The error involves a label mixup during repacking.

    Product
    CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.
    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-773-2014·2014-01-29

    Aidapak Recalls Calcium Carbonate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Calcium Carbonate/Cholecalciferol tablets because they may be mislabeled as Repaglinide. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00005550924.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-819-2014·2014-01-29

    Valsartan 40 mg Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Valsartan 40 mg tablets because they may have been mislabeled as Valsartan 80 mg or Zinc Sulfate 50 mg.

    Product
    VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078042315.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-810-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Levothyroxine Sodium tablets due to a potential label mixup with Magnesium Chloride. The repacked drugs were distributed in four western states.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074706890.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-994-2014·2014-01-29

    Sulfasalazine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 500 mg sulfasalazine tablets that may be mislabeled as fluconazole or phenytoin sodium.

    Product
    sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1013-2014·2014-01-29

    Aidapak Recalls Amantadine HCL Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Amantadine HCL 100 mg tablets because they may have been mislabeled as other medications.

    Product
    AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
    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-926-2014·2014-01-29

    Aidapak Recalls Acetaminophen Chew Tablets Due to Labeling Mixup

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

    Product
    ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1023-2014·2014-01-29

    Aidapak Recalls Niacin TR Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Niacin TR capsules because they may have been mislabeled as Methylergonovine Maleate tablets.

    Product
    NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-752-2014·2014-01-29

    Theraflu Cold Powder Recalled for Potential Foreign Substances

    Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets because they may contain foreign substances.

    Product
    THERAFLU — THERAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0819-2014·2014-01-29

    FDA Recalls Composix L/P Mesh Due to Labeling Mismatch

    Davol, Inc. is recalling 19 units of Composix L/P Mesh with Echo PS Positioning System because the product labeling does not match the product configuration.

    Product
    Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-925-2014·2014-01-29

    Nicotine Polacrilex Gum Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling 2 mg Nicotine Polacrilex Gum due to a potential labeling mixup with Folic Acid or Quetiapine Fumarate tablets.

    Product
    NICOTINE POLACRILEX, GUM, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536302923.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-946-2014·2014-01-29

    Lactobacillus Acidophilus Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Lactobacillus Acidophilus tablets because they may have been mislabeled as Repaglinide.

    Product
    LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-884-2014·2014-01-29

    Aidapak Recalls Gabapentin Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Gabapentin 600 mg tablets because they may have been mislabeled as Aripiprazole 15 mg.

    Product
    GABAPENTIN, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228263611.
    Category
    Drug
    Distribution
    4 states
  • 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-869-2014·2014-01-29

    Repaglinide Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Repaglinide 2 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008481.
    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-876-2014·2014-01-29

    Aidapak Recalls Sennosides Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Sennosides tablets because they may have been mislabeled as other medications. The recall covers distribution in four western states.

    Product
    SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-840-2014·2014-01-29

    FDA Recalls Nefazodone Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Nefazodone HCL 150 mg tablets because they may have been mislabeled as Liothyronine Sodium 25 mcg.

    Product
    NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093711306.
    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-1000-2014·2014-01-29

    Aidapak Recalls Isosorbide Dinitrate Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Isosorbide Dinitrate 10 mg tablets because they may have been mislabeled as Sodium Chloride or Calcitriol.

    Product
    ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-933-2014·2014-01-29

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 923 tablets of Cyanocobalamin 1000 mcg because they may have been mislabeled as other medications.

    Product
    CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355601.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0794-2014·2014-01-29

    Remel Recalls Oxoid Ampicillin Test Discs Due to Missing Antibiotic

    Remel Inc is recalling 80 packs of Oxoid Ampicillin 10 mcg test discs because some cartridges may contain discs not impregnated with antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-767-2014·2014-01-29

    Aidapak Recalls Atomoxetine Capsules Due to Potential Lovastatin Label Mixup

    Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as Lovastatin tablets. The repacked drugs were distributed in four western states.

    Product
    ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0814-2014·2014-01-29

    Bard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters

    Bard Access Systems is recalling MRI Low Profile Single Lumen ports because some silicone catheters may be undersized to 5.3 Fr instead of the labeled 6.6 Fr.

    Product
    MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-762-2014·2014-01-29

    Novartis Recalls Theraflu Exte Powder Packets Due to Foreign Substances

    Novartis Consumer Health is recalling Theraflu Exte powder packets because they may contain foreign substances. The recall covers products distributed in the U.S. and several international markets.

    Product
    Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distribut
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-835-2014·2014-01-29

    Aidapak Recalls Pioglitazone Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Pioglitazone HCL 15 mg tablets because they may have been mislabeled as Doxycycline or Lovastatin.

    Product
    PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093204856.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-782-2014·2014-01-29

    Aidapak Recalls Dronedarone HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Dronedarone HCL 400 mg tablets because they may be mislabeled as Methylergonovine Maleate 0.2 mg.

    Product
    DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-791-2014·2014-01-29

    FDA Recalls Lithium Carbonate ER Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Lithium Carbonate ER tablets because they may be mislabeled as Vitamin B Complex Prolonged Release tablets.

    Product
    LITHIUM CARBONATE ER, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002125.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-891-2014·2014-01-29

    Aidapak Recalls Atropine Sulfate/Diphenoxylate Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling Atropine Sulfate/Diphenoxylate HCL tablets because they may have been mislabeled as Cyanocobalamin or Tri-Buffered Aspirin.

    Product
    ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378041501.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-902-2014·2014-01-29

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling 40 mg atorvastatin calcium tablets that may have been mislabeled as 10 mg atorvastatin or 5 mg finasteride.

    Product
    ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212177 .
    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-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 (Drugs)·D-996-2014·2014-01-29

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 5,000-unit Cholecalciferol tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
    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-932-2014·2014-01-29

    Aidapak Recalls Mislabeled Cyanocobalamin Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling 500 mcg Cyanocobalamin tablets that were mislabeled as Sevelamer Carbonate or other drugs. The recall covers products distributed in Arizona, California, Oregon, and Washington.

    Product
    CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355101.
    Category
    Drug
    Distribution
    4 states

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