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.

601–700 of 1423

  • ModerateFDA (Drugs)·D-676-2014·2014-01-22

    Aidapak Recalls Calcitriol Capsules Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Calcitriol 0.5 mcg capsules because they may be mislabeled as Niacin or Isoniazid. The repacked drugs were distributed in four western states.

    Product
    CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-611-2014·2014-01-22

    Aidapak Recalls Doxycycline Hyclate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Doxycycline Hyclate 100 mg tablets because they may be mislabeled as Desloratadine 5 mg tablets.

    Product
    DOXYCYCLINE HYCLATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489012002
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-622-2014·2014-01-22

    Aidapak Recalls Glimepiride Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1 mg Glimepiride tablets because they may be mislabeled as Clomipramine HCl capsules.

    Product
    GLIMEPIRIDE Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111032001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-551-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Vitamin B Complex Prolonged Release tablets because they may be mislabeled as guaiFENesin ER or tolterodine tartrate ER.

    Product
    VITAMIN B COMPLEX PROLONGED RELEASE Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-692-2014·2014-01-22

    Lisinopril Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Lisinopril 2.5 mg tablets because they may be mislabeled as Ranolazine ER or Docusate Sodium.

    Product
    LISINOPRIL Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679092701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-558-2014·2014-01-22

    Aidapak Recalls Pancrelipase DR Capsules Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Pancrelipase DR capsules because they may be mislabeled as Melatonin or Verapamil HCL. The repacked drugs were distributed in four western states.

    Product
    PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 42865010302
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-577-2014·2014-01-22

    Nitrofurantoin Capsules Recalled for Potential Mislabeling as Minocycline

    Aidapak Services is recalling Nitrofurantoin capsules that may be mislabeled as Minocycline. The error could lead to patients receiving the wrong medication.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-533-2014·2014-01-22

    Aidapak Recalls Acarbose Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Acarbose 25 mg tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155014701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-623-2014·2014-01-22

    Aidapak Recalls Mislabeled Modafinil Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Modafinil 50 mg tablets that may be mislabeled as Saccharomyces boulardii capsules due to a labeling mixup.

    Product
    MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-661-2014·2014-01-22

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atorvastatin Calcium 20 mg tablets because they may be mislabeled as GuaiFENesin ER 600 mg.

    Product
    ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-505-2014·2014-01-22

    Aidapak Omega-3 Fatty Acid Capsules Recalled for Potential Mislabeling

    Aidapak Services, LLC is recalling Omega-3 Fatty Acid capsules because they may be mislabeled as tizanidine HCL tablets.

    Product
    OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11845014882
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-566-2014·2014-01-22

    FDA Recalls Orphenadrine Citrate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Orphenadrine Citrate ER tablets because they may be mislabeled as Omega-3 Fatty Acid capsules.

    Product
    ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-573-2014·2014-01-22

    Aidapak Recalls buPROPion HCl ER Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling buPROPion HCl ER 200 mg tablets because they may be mislabeled as amantadine HCl 100 mg capsules.

    Product
    buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-603-2014·2014-01-22

    Warfarin Sodium Tablets Recalled Due to Potential Labeling Error

    Aidapak Services is recalling Warfarin Sodium 0.5 mg tablets that may be mislabeled as Sodium Chloride 1 mg tablets.

    Product
    WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-610-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 50,000-unit Cholecalciferol capsules because they may be mislabeled as Fenofibrate tablets. The repacked drugs were distributed in four western states.

    Product
    CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 53191036201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0778-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-677-2014·2014-01-22

    Aidapak Recalls Hydroxychloroquine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydroxychloroquine Sulfate 200 mg tablets because they may be mislabeled as Guanfacine HCl 1 mg.

    Product
    HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-471-2014·2014-01-22

    FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Valsartan, Lactobacillus, or Pyridoxine.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0725-2014·2014-01-22

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

    GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

    Product
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-467-2014·2014-01-22

    Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-520-2014·2014-01-22

    Aidapak Recalls Losartan Potassium Tablets Due to Labeling Mixup

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

    Product
    LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058102
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-586-2014·2014-01-22

    Glycopyrrolate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Glycopyrrolate 2 mg tablets because they may be mislabeled as Lactobacillus tablets.

    Product
    GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0756-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-537-2014·2014-01-22

    Aidapak Recalls Lactase Enzyme Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lactase Enzyme Tablets because they may be mislabeled as other medications. The recall covers 2,872 tablets distributed in four western states.

    Product
    LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385014976
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0753-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1393-2014·2014-01-22

    Jensen's Recalls Low Salt Vacuum Packaged Smoked Salmon Products

    Jensen's Old Fashioned Smokehouse is recalling low salt, vacuum packaged smoked salmon products not labeled 'KEEP FROZEN'.

    Product
    Low salt, vacuum packaged, Hot Smoked King Nova Salmon. The following is information on the individual products for Alaska King Seafoods brand: All AKS stands for Alaska King Seafoods product labels contain the following statement above or below the product name and/or…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-588-2014·2014-01-22

    Aidapak Recalls Doxycycline Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Doxycycline Monohydrate capsules because they may be mislabeled as Diphenhydramine or Dutasteride.

    Product
    DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0758-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.

    Product
    MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-541-2014·2014-01-22

    Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0777-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.

    Product
    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-698-2014·2014-01-22

    FDA Recalls Mislabeled Febuxostat Tablets Due to Label Mixup

    Aidapak Services is recalling Febuxostat 40 mg tablets that may be mislabeled as other medications due to a labeling error.

    Product
    FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-703-2014·2014-01-22

    Aidapak Recalls Disulfiram Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Disulfiram 250 mg tablets because they may be mislabeled as Pyridoxine HCl 50 mg.

    Product
    DISULFIRAM Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980017101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-538-2014·2014-01-22

    Nicotine Polacrilex Gum Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Nicotine Polacrilex Gum, 2 mg, due to a potential labeling mixup with Saccharomyces boulardii capsules.

    Product
    NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24385059471
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-640-2014·2014-01-22

    Aripiprazole Tablets Recalled Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Aripiprazole 15 mg tablets because they may be mislabeled as Atomoxetine or Pramipexole.

    Product
    ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-730-2014·2014-01-22

    Verapamil HCL ER Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Verapamil HCL ER 240 mg tablets because they may be mislabeled as Trifluoperazine HCL 1 mg.

    Product
    VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-678-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Metoprolol Tartrate tablets because they may be mislabeled as Pioglitazone or Levothyroxine Sodium.

    Product
    METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304057901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-669-2014·2014-01-22

    FDA Recalls Isosorbide Mononitrate Tablets Due to Labeling Error

    Aidapak Services is recalling Isosorbide Mononitrate 10 mg tablets that may be mislabeled as Ascorbic Acid 250 mg. The error affects specific lots distributed in four western states.

    Product
    ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-495-2014·2014-01-22

    Aidapak Recalls Naproxen Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Naproxen 500 mg tablets because they may be mislabeled as Thiothixene or Hydrochlorothiazide.

    Product
    NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-732-2014·2014-01-22

    Rasagiline Mesylate Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Rasagiline Mesylate tablets because they may be mislabeled as Omega-3 Fatty Acid capsules.

    Product
    RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-407-2014·2014-01-22

    B. Braun Recalls Sodium Chloride Injection Due to Incorrect Bar Code Labeling

    B. Braun Medical Inc. is recalling 19,572 bags of 0.45% Sodium Chloride Injection because the bar code incorrectly identifies the product as Potassium Chloride.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-555-2014·2014-01-22

    FDA Recalls Potentially Mislabeled Levothyroxine/Liothyronine Tablets

    Aidapak Services is recalling Levothyroxine/Liothyronine tablets that may be mislabeled as Magnesium Gluconate Dihydrate.

    Product
    LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0765-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation and directions for use were unclear.

    Product
    MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-581-2014·2014-01-22

    Lactobacillus GG Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lactobillus GG capsules because they may be mislabeled as aspirin, zonisamide, or venlafaxine.

    Product
    LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-556-2014·2014-01-22

    Liothyronine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Liothyronine Sodium 5 mcg tablets because they may be mislabeled as Hydrochlorothiazide 12.5 mg.

    Product
    LIOTHYRONINE SODIUM, Tablet, 5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001802
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·F-1396-2014·2014-01-22

    Jensen's Recalls Unlabeled Hot Smoked Salmon Products

    Jensen's Old Fashioned Smokehouse is recalling Great Ruby Fish Co. and Rolf's Choice hot smoked salmon products that lack 'KEEP FROZEN' labels.

    Product
    Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker and "KEEP FROZEN" sticker on individual units. The customer applies their own label upon receipt. Rolf's Choice Sockeye hot smoked…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-584-2014·2014-01-22

    Nicotine Polacrilex Lozenges Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 2 mg Nicotine Polacrilex Lozenges because they may be mislabeled as Vitamin B Complex tablets.

    Product
    NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49348085216
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-469-2014·2014-01-22

    FDA Recalls Pseudoephedrine Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling pseudoephedrine HCL tablets because they may be mislabeled as d-alpha tocopheryl acetate capsules.

    Product
    PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0766-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-693-2014·2014-01-22

    Zonisamide Capsules Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Zonisamide capsules that may be mislabeled as Phytonadione tablets due to a labeling error.

    Product
    ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-549-2014·2014-01-22

    FDA Recalls Coenzyme Q-10 Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Coenzyme Q-10 capsules because they may be mislabeled as other prescription or over-the-counter medications.

    Product
    COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-656-2014·2014-01-22

    Sennosides Tablets Recalled for Potential Labeling Mixup with Saccharomyces Boulardii

    Aidapak Services, LLC is recalling Sennosides Tablets due to a potential labeling mixup with Saccharomyces Boulardii capsules. The error involves incorrect product identification on the label.

    Product
    SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0767-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-548-2014·2014-01-22

    Aidapak Recalls Multivitamin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling multivitamin tablets that may be mislabeled as quetiapine or docusate sodium. The recall covers specific lots distributed in four western states.

    Product
    MULTIVITAMIN/MULTIMINERAL Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205018581
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-543-2014·2014-01-22

    Aidapak Recalls Cranberry Extract Capsules Due to Label Mixup

    Aidapak Services is recalling Cranberry Extract/Vitamin C capsules because they may be mislabeled as other medications. The products were distributed in four western states.

    Product
    CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-489-2014·2014-01-22

    Aidapak Recalls Ferrous Sulfate Tablets Due to Potential Label Mixup

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

    Product
    FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0769-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2014·2014-01-22

    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall

    Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-513-2014·2014-01-22

    Prednisone Tablets Recalled for Potential Label Mixup with Aspirin

    Aidapak Services is recalling prednisone tablets that may be mislabeled as aspirin/dipyridamole capsules due to a labeling error.

    Product
    prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 16477050501
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-560-2014·2014-01-22

    Lactobacillus Acidophilus Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Lactobacillus Acidophilus capsules because they may be mislabeled as Melatonin or Cranberry Extract products.

    Product
    LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292050022
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-637-2014·2014-01-22

    Aidapak Recalls Sevelamer Carbonate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Sevelamer Carbonate tablets because they may be mislabeled as other prescription drugs.

    Product
    SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-687-2014·2014-01-22

    Aidapak Recalls Multivitamin Chew Tablets Due to Labeling Error

    Aidapak Services is recalling multivitamin chew tablets that may be mislabeled as a different prescription medication.

    Product
    MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081501
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-612-2014·2014-01-22

    Aidapak Recalls Trimethobenzamide Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Trimethobenzamide HCl capsules because they may be mislabeled as other medications. The affected drugs were distributed in four western states.

    Product
    TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-572-2014·2014-01-22

    Aidapak Recalls Acetaminophen Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific acetaminophen tablets that may be mislabeled as multivitamin chew tablets. The error involves a label mixup.

    Product
    ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 46122010478
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-695-2014·2014-01-22

    Aidapak Recalls Hydrocortisone Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Hydrocortisone 5 mg tablets that may be mislabeled as Orphenadrine Citrate ER or Calcium Acetate.

    Product
    HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-618-2014·2014-01-22

    Lactobacillus Acidophilus Capsules Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Lactobacillus Acidophilus capsules due to a potential labeling mixup with other medications.

    Product
    LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629011101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-534-2014·2014-01-22

    Venlafaxine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Venlafaxine HCL 50 mg tablets because they may be mislabeled as sulfasalazine 500 mg.

    Product
    VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155024801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-702-2014·2014-01-22

    Aidapak Recalls aMILoride Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling aMILoride HCl 5 mg tablets because they may be mislabeled as Propranolol HCl 10 mg or Famotidine 20 mg.

    Product
    aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-485-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 1,199 tablets of Cholecalciferol 400 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-614-2014·2014-01-22

    Aidapak Recalls Mesalamine Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Mesalamine CR capsules because they may be mislabeled as clomipramine HCl. The repacked drugs were distributed in four western states.

    Product
    MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092019112
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-525-2014·2014-01-22

    Aidapak Recalls Hydrochlorothiazide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydrochlorothiazide 12.5 mg tablets because they may be mislabeled as Chlordiazepoxide HCl 25 mg capsules.

    Product
    HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16729018201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-690-2014·2014-01-22

    Aidapak Recalls 40 mg Pantoprazole Sodium Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 1,001 tablets of 40 mg Pantoprazole Sodium due to a potential labeling mixup with Sennosides.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043402
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-647-2014·2014-01-22

    Medroxyprogesterone Acetate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Medroxyprogesterone Acetate tablets that may be mislabeled as Hydralazine HCl.

    Product
    medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762374202
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-500-2014·2014-01-22

    Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Solifenacin Succinate.

    Product
    NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-605-2014·2014-01-22

    FDA Recalls Melatonin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 3 mg Melatonin tablets because they may be mislabeled as other medications like Docusate Sodium or Pioglitazone.

    Product
    MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-737-2014·2014-01-22

    Greenstone Recalls Nifedipine Tablets Due to Incorrect Expiration Date Labeling

    Greenstone LLC is recalling Nifedipine extended-release tablets because the package displays a 48-month expiration date instead of the correct 36-month date.

    Product
    Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device validation.

    Product
    MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0732-2014·2014-01-22

    Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias

    Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.

    Product
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-592-2014·2014-01-22

    Aidapak Recalls Trazodone Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Dexamethasone, Docusate Sodium, or Guanfacine.

    Product
    traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-463-2014·2014-01-22

    Aidapak Recalls Zinc Glucosate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Zinc Glucosate tablets because they may be mislabeled as Ascorbic Acid chew tablets.

    Product
    ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-476-2014·2014-01-22

    Aidapak Recalls Acetaminophen Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Acetaminophen/Aspirin/Caffeine tablets that may be mislabeled as Naproxen. The error could lead to incorrect medication use.

    Product
    ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0716-2014·2014-01-22

    Biomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error

    Biomet is recalling 52 locking cortical screws because a 3.5mmx28mm screw was incorrectly labeled as a 3.5mmx38mm screw.

    Product
    Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-466-2014·2014-01-22

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1,821 tablets of Cyanocobalamin 1000 mcg due to a potential label mixup with other medications.

    Product
    CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-651-2014·2014-01-22

    Zinc Sulfate Capsules Recalled for Potential Labeling Errors

    Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Calcium Acetate or Calcitrol due to a labeling mixup.

    Product
    ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-705-2014·2014-01-22

    Riluzole Tablets Recalled for Potential Labeling Mixup with Trazodone

    Aidapak Services, LLC is recalling Riluzole 50 mg tablets due to a labeling error where they may be mislabeled as Trazodone HCl 150 mg.

    Product
    RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-563-2014·2014-01-22

    Aidapak Recalls Methylergonovine Maleate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Methylergonovine Maleate tablets because they may be mislabeled as Isosorbide Mononitrate or Levothyroxine Sodium.

    Product
    METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-657-2014·2014-01-22

    Fosinopril Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 10 mg Fosinopril Sodium tablets that may be mislabeled as Calcitriol capsules due to a labeling mixup.

    Product
    FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251002
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-552-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Vitamin B Complex Prolonged Release tablets because they may be mislabeled as other medications like Coenzyme Q-10 or Aspirin.

    Product
    VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-512-2014·2014-01-22

    Aidapak Recalls Prenatal Multivitamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Prenatal Multivitamin/Multimineral tablets because they may be mislabeled as Cyanocobalamin tablets. The error involves a label mixup.

    Product
    PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 13811051410
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0744-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-546-2014·2014-01-22

    Magnesium Gluconate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Magnesium Gluconate tablets that may be mislabeled as Fluvastatin capsules due to a label mixup.

    Product
    MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000322
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-707-2014·2014-01-22

    Promethazine HCL Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Promethazine HCL tablets that may be mislabeled as Cholecalciferol due to a labeling mixup.

    Product
    PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-708-2014·2014-01-22

    Aidapak Recalls Flecaïnide Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Flecaïnide Acetate tablets that may be mislabeled as Vitamin B Complex with C due to a labeling error.

    Product
    FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-547-2014·2014-01-22

    FDA Recalls Mislabeled Melatonin Tablets Distributed by Aidapak Services

    Aidapak Services is recalling 1 mg melatonin tablets that may be mislabeled as cranberry extract or glycopyrrolate. The FDA classifies this as a Class II recall.

    Product
    MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-517-2014·2014-01-22

    Fluoxetine Capsules Recalled Due to Potential Labeling Error

    Aidapak Services is recalling Fluoxetine HCl capsules because they may be mislabeled as Pancrelipase DR.

    Product
    FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0763-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-713-2014·2014-01-22

    Aidapak Recalls Benazepril HCL Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 799 Benazepril HCL tablets because they may be mislabeled as other medications.

    Product
    BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075410
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-662-2014·2014-01-22

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atorvastatin Calcium 80 mg tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505267109
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-652-2014·2014-01-22

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 500 mg Ascorbic Acid tablets that may be mislabeled as Febuxostat 40 mg. The error could lead to incorrect medication administration.

    Product
    ASCORBIC ACID Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258014101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-665-2014·2014-01-22

    Quetiapine Fumarate Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 1,300 Quetiapine Fumarate 100 mg tablets because they may be mislabeled as other medications.

    Product
    QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301
    Category
    Drug
    Distribution
    4 states

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