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.

701–800 of 1423

  • ModerateFDA (Drugs)·D-564-2014·2014-01-22

    Misoprostol Tablets Recalled for Potential Labeling Error

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

    Product
    MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-591-2014·2014-01-22

    Aidapak Recalls Mislabeled HydrALAZINE HCl Tablets

    Aidapak Services, LLC is recalling hydrALAZINE HCl 50 mg tablets that may be mislabeled as CapsuleTOPRIL 12.5 mg tablets.

    Product
    hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-507-2014·2014-01-22

    Aidapak Recalls Paroxetine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Paroxetine HCl 10 mg tablets because they may be mislabeled as Pantoprazole Sodium DR 20 mg.

    Product
    PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-663-2014·2014-01-22

    Olanzapine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Olanzapine 7.5 mg tablets due to a potential labeling mixup with Nortriptyline HCL capsules.

    Product
    OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-685-2014·2014-01-22

    FDA Recalls Benzoicaine/Menthol Lozenges Due to Potential Labeling Mixup

    Aidapak Services is recalling Benzoicaine/Menthol lozenges that may be mislabeled as Lubiprostone or Losartan Potassium.

    Product
    BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016
    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 (Devices)·Z-0749-2014·2014-01-22

    Anspach Micro Curved Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling Micro Curved Attachment Cutting Burrs because the indications for use were broader than validated and directions were unclear.

    Product
    Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA 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-728-2014·2014-01-22

    Fluconazole Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 50 mg fluconazole tablets that may be mislabeled as 200 mg tablets.

    Product
    FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-515-2014·2014-01-22

    Aidapak Recalls Allopurinol Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Allopurinol 300 mg tablets because they may be mislabeled as Cholecalciferol 400 units.

    Product
    ALLOPURINOL Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714004204
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-638-2014·2014-01-22

    Multivitamin Chew Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Multivitamin/Multimineral Chew Tablets because they may be mislabeled as Levothyroxine Sodium or Lactobacillus Acidophilus.

    Product
    MULTIVITAMIN/MULTIMINERAL Chew Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 58914001460
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-481-2014·2014-01-22

    Aidapak Recalls Glucosamine/Chondroitin Capsules Due to Labeling Errors

    Aidapak Services, LLC is recalling Glucosamine/Chondroitin DS capsules because they may be mislabeled as other medications. The products were distributed in four western states.

    Product
    GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-655-2014·2014-01-22

    Aidapak Recalls Cyproheptadine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Cyproheptadine HCL 4 mg tablets because they may be mislabeled as other medications.

    Product
    CYPROHEPTADINE HCL Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60258085001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0755-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

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

    Product
    MCA5-15SD - 1.5MM 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 (Drugs)·D-580-2014·2014-01-22

    FDA Recalls Lactobacillus GG Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lactobacillus GG capsules because they may be mislabeled as guaiFENesin ER tablets. The repacked drugs were distributed in four western states.

    Product
    LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-654-2014·2014-01-22

    Magnesium Gluconate Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Magnesium Gluconate Dihydrate tablets because they may be mislabeled as hydrALAZINE HCl.

    Product
    MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258017201
    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 (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 (Devices)·Z-0768-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

    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
    MCA7-2SB - 2MM 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-686-2014·2014-01-22

    Aidapak Recalls Benzoicaine/Menthol Lozenges Due to Labeling Error

    Aidapak Services, LLC is recalling Benzoicaine/Menthol lozenges because they may be mislabeled as Cholecalciferol/Calcium/Phosphorus tablets.

    Product
    BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116
    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-540-2014·2014-01-22

    Aidapak Recalls Caffeine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 200 mg caffeine tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173
    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
  • ModerateFDA (Drugs)·D-617-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Capsules Due to Labeling Mixup

    Aidapak Services is recalling Vitamin B Complex capsules because they may be mislabeled as Sodium Chloride tablets. The recall covers 2,398 capsules distributed in four western states.

    Product
    VITAMIN B COMPLEX W/C Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629008001
    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-561-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Vitamin B Complex tablets because they may be mislabeled as Omeprazole or Prednisone.

    Product
    VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055540
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-712-2014·2014-01-22

    Aidapak Recalls Benazepril HCL Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Benazepril HCL 5 mg tablets because they may be mislabeled as Zinc Sulfate 220 mg capsules.

    Product
    BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075110
    Category
    Drug
    Distribution
    4 states
  • 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 (Drugs)·D-492-2014·2014-01-22

    Magnesium Chloride Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Magnesium Chloride tablets that may be mislabeled as Selegiline HCL or Phosphorus due to a label mixup.

    Product
    MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904791152
    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 (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 ingre
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-710-2014·2014-01-22

    Multivitamin Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Multivitamin/Multimineral tablets that may be mislabeled as Omega-3 or Guaifenesin products.

    Product
    MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066850
    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-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-406-2014·2014-01-22

    Betachem Recalls Metformin Hydrochloride API Due to CGMP Deviations

    Betachem, Inc. is recalling 27,000 kilos of Metformin Hydrochloride USP active pharmaceutical ingredient because it was not manufactured according to current good manufacturing practices.

    Product
    Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-
    Category
    Drug
    Distribution
    1 state
  • 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-501-2014·2014-01-22

    Aidapak Recalls Omeprazole Capsules Due to Potential Labeling Mixup

    Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Cyanocobalamin or Omega-3 fatty acid products.

    Product
    OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-571-2014·2014-01-22

    Desipramine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Desipramine HCL tablets that may be mislabeled as clomipramine HCl capsules due to a label mixup.

    Product
    DESIPRAMINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45963034302
    Category
    Drug
    Distribution
    4 states
  • 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 (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-628-2014·2014-01-22

    Aidapak Recalls Metoprolol Tartrate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 402 Metoprolol Tartrate tablets because they may be mislabeled as Docusate Sodium capsules.

    Product
    METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
    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 (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-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-598-2014·2014-01-22

    Solifenacin Succinate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Solifenacin Succinate 5 mg tablets because they may be mislabeled as Bromocriptine Mesylate 2.5 mg.

    Product
    SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51248015001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-576-2014·2014-01-22

    Aidapak Recalls Melatonin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1 mg Melatonin tablets because they may be mislabeled as other medications. The affected products were distributed in four western states.

    Product
    MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 47469000466
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0715-2014·2014-01-22

    Anspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions

    The Anspach Effort, Inc. is recalling MCA Cutting Burs because the current directions for use do not provide sufficient details regarding the intended use for these specific burs.

    Product
    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-607-2014·2014-01-22

    Neomycin Sulfate Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Neomycin Sulfate tablets that may be mislabeled as Imipramine HCl. The error could lead to incorrect medication administration.

    Product
    NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51991073801
    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-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 (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-733-2014·2014-01-22

    Aidapak Recalls Magnesium Chloride Tablets Due to Labeling Mixup

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

    Product
    MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 68585000575
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-539-2014·2014-01-22

    Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The affected 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 (Drugs)·D-729-2014·2014-01-22

    Fluconazole Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Fluconazole 100 mg tablets because they may be mislabeled as Prenatal Multivitamin/Multimineral tablets.

    Product
    FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
    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-636-2014·2014-01-22

    Sevelamer HCl Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Sevelamer HCl tablets that may be mislabeled as Ranolazine ER due to a labeling mixup.

    Product
    SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
    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-506-2014·2014-01-22

    FDA Recalls Chlorophyllin Copper Complex Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Chlorophyllin Copper Complex tablets that may be mislabeled as trazodone hydrochloride.

    Product
    CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901
    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-668-2014·2014-01-22

    Metoprolol Succinate ER Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Metoprolol Succinate ER 200 mg tablets due to a potential labeling mixup. The affected repacked drugs were distributed in four western states.

    Product
    METOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62037083301
    Category
    Drug
    Distribution
    4 states
  • 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-629-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may be mislabeled as Ascorbic Acid or Amlodipine Besylate.

    Product
    METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-565-2014·2014-01-22

    Nifedipine Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Nifedipine 10 mg capsules due to a potential label mixup with multivitamin products.

    Product
    NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-567-2014·2014-01-22

    Aidapak Recalls Isometheptene Mucate Capsules Due to Labeling Errors

    Aidapak Services, LLC is recalling Isometheptene Mucate capsules because they may be mislabeled as other medications. The error could lead to patients receiving the wrong drug.

    Product
    ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-487-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

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

    Product
    CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-718-2014·2014-01-22

    Aidapak Recalls Phenobarbital Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Phenobarbital/Hyoscyamine/Atropine/Scopolamine tablets because they may be mislabeled as Valsartan. The repacked drugs were distributed in four western states.

    Product
    PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-583-2014·2014-01-22

    Aidapak Recalls D-Alpha Tocopheryl Acetate Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling D-Alpha Tocopheryl Acetate capsules because they may be mislabeled as Cyanocobalamin tablets.

    Product
    D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348041010
    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 (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-726-2014·2014-01-22

    Aidapak Recalls Amlodipine Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 10 mg amlodipine besylate tablets that may be mislabeled as 5 mg finasteride tablets.

    Product
    amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-554-2014·2014-01-22

    FDA Recalls Fexofenadine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Fexofenadine HCL 180 mg tablets because they may be mislabeled as Multivitamin/Multimineral tablets.

    Product
    FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 41167412003
    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-679-2014·2014-01-22

    Aidapak Recalls Mislabeled Atenolol Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atenolol tablets that may be mislabeled as Vitamin B Complex or Piroxicam. The error involves specific pedigree codes and expiration dates.

    Product
    ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-674-2014·2014-01-22

    Aidapak Recalls OXcarbazepine Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling OXcarbazepine 600 mg tablets that may be mislabeled as Lactase Enzyme 3000 units. The error could lead to patients receiving the wrong medication.

    Product
    OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0761-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

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

    Product
    MCA7-06SD - 0.6MM 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-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 (Drugs)·D-523-2014·2014-01-22

    Sertraline HCL Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Sertraline HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-648-2014·2014-01-22

    Sulfasalazine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Sulfasalazine 500 mg tablets because they may be mislabeled as Hyoscyamine Sulfate 0.125 mg.

    Product
    sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-631-2014·2014-01-22

    FDA Recalls Isosorbide Dinitrate Tablets Due to Labeling Error

    Aidapak Services is recalling Isosorbide Dinitrate ER tablets because they may be mislabeled as Cilostazol. Patients should check their medication labels.

    Product
    ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-590-2014·2014-01-22

    Aidapak Recalls Hydralazine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets because they may be mislabeled as Docusate Calcium 240 mg capsules.

    Product
    HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-599-2014·2014-01-22

    Aidapak Recalls Pyridoxine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-593-2014·2014-01-22

    Trazodone HCl Tablets Recalled Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Amantadine HCl 100 mg.

    Product
    traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0759-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

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

    Product
    MCA5-2SD - 2MM 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 (Drugs)·D-499-2014·2014-01-22

    Aidapak Recalls Itraconazole Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Itraconazole capsules because they may be mislabeled as Famciclovir tablets. The error could lead to patients receiving the wrong medication.

    Product
    ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
    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 (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 (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 (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-625-2014·2014-01-22

    Cinacalcet HCL Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Cinacalcet HCL 60 mg tablets because they may be mislabeled as Ranolazine ER 500 mg.

    Product
    CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-719-2014·2014-01-22

    Aidapak Recalls Mislabeled Carbamazepine ER Capsules

    Aidapak Services, LLC is recalling 229 capsules of carbamazepine ER 200 mg due to a labeling mixup where the product may be mislabeled as acamprosate calcium.

    Product
    carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0734-2014·2014-01-22

    Remel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs because individual discs may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Product
    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-624-2014·2014-01-22

    FDA Recalls Cinacalcet HCL Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 30 mg Cinacalcet HCL tablets because they may be mislabeled as other medications like acetaminophen or ferrous sulfate.

    Product
    CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
    Category
    Drug
    Distribution
    4 states
  • 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 (Devices)·Z-0754-2014·2014-01-22

    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
    MCA5-15SB - 1.5MM 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-659-2014·2014-01-22

    Cilostazol Tablets Recalled for Potential Labeling Mixup with Dutasteride

    Aidapak Services is recalling Cilostazol 100 mg tablets due to a labeling mixup where they may be mislabeled as Dutasteride 0.5 mg capsules.

    Product
    CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0776-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.

    Product
    Arena-L Trial Handle; Part: 11-81002 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, each with multiple height configurations. The Trial Heads are
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0731-2014·2014-01-22

    GE Centricity PACS System Recalled for Potential Image Loss During Transfer

    GE Healthcare is recalling Centricity PACS System versions 3.X and 4.X due to a potential loss of diagnostic images during transfers between servers.

    Product
    Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-578-2014·2014-01-22

    Aidapak Recalls Nitrofurantoin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Nitrofurantoin Macrocrystals capsules because they may be mislabeled as Phytonadione tablets.

    Product
    NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0764-2014·2014-01-22

    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
    MCA7-15SB - 1.5MM 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-531-2014·2014-01-22

    FDA Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets because they may be mislabeled as Lactobacillus Acidophilus capsules.

    Product
    PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011010
    Category
    Drug
    Distribution
    4 states

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