The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
228
High
281
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

Which agencies issued them

101–200 of 833

  • ModerateFDA (Drugs)·D-0529-2018·2018-02-28

    FDA Recalls Tramadol HCl for Prescription Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Tramadol HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2018·2018-02-28

    FDA Recalls Doxycycline Hyclate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0689-2018·2018-02-28

    Philips Ear Thermometers Recalled for Inaccurate Temperature Readings

    Philips Consumer Lifestyle is recalling specific ear thermometer models because they may provide inaccurate measurements.

    Product
    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0482-2018·2018-02-28

    Cyclosporine USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Cyclosporine USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Feedback and Injury Information

    Philips is recalling QCPR meters used with HeartStart defibrillators to inform users of correct pad placement and CPR-related injuries.

    Product
    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2018·2018-02-28

    FDA Recalls Ketamine HCl USP for Prescription Compounding Due to Stability Data Issues

    American Pharmaceutical Ingredients LLC is recalling Ketamine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0659-2018·2018-02-28

    Fujifilm Aspire HD Mammography System Recalled for Image ID Error

    Fujifilm is recalling Aspire HD mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0538-2018·2018-02-28

    FDA Recalls Vitamin B12 Compounding Ingredient Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Cyanocobalamin USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2018·2018-02-28

    Lidocaine HCl USP Recalled for Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2018·2018-02-28

    Levofloxacin Hemihydrate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2018·2018-02-28

    Hologic Recalls Rapid for TLiIQ System Kits Due to Unapproved Material

    Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.

    Product
    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0521-2018·2018-02-28

    Sumatriptan Succinate USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sumatriptan Succinate USP for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2018·2018-02-28

    Flurbiprofen USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.

    Product
    Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2018·2018-02-28

    FDA Recalls Clindamycin Phosphate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2018·2018-02-28

    Arrow International Recalls Hemodialysis Catheterization Kits with Incorrect Guide

    Arrow International Inc is recalling specific lots of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2018·2018-02-28

    FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.

    Product
    Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2018·2018-02-28

    Amitriptyline HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data supporting the assigned expiration dates.

    Product
    Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2018·2018-02-28

    FDA Recalls Levetiracetam USP for Prescription Compounding Due to Stability Issues

    American Pharmaceutical Ingredients LLC is recalling Levetiracetam USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2018·2018-02-28

    Oculus Pentacam AXL Software Recall for Erroneous Quality Markings

    Oculus Optikgeraete GmbH is recalling 83 Pentacam AXL devices due to a software anomaly that may produce erroneous quality specification markings.

    Product
    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0484-2018·2018-02-28

    FDA Recalls Diclofenac Sodium USP Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Diclofenac Sodium USP for prescription compounding because it lacks stability data to support expiration dates.

    Product
    Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0660-2018·2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0519-2018·2018-02-28

    Sildenafil Citrate USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sildenafil Citrate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredien
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2018·2018-02-28

    Tadalafil USP Recall Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Tadalafil USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highlan
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2018·2018-02-28

    FDA Recalls Vancomycin HCl Due to Missing Stability Data

    American Pharmaceutical Ingredients is recalling Vancomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2018·2018-02-28

    Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

    Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

    Product
    ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is in
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0500-2018·2018-02-28

    Ketoprofen USP Micronized Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Ketoprofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps

    American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.

    Product
    Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0673-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size. The components are intended for use in total knee arthroplasty.

    Product
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

    Arrow International Inc is recalling 5,926 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0663-2018·2018-02-28

    Zimmer NexGen LPS Femoral Component Recalled for Packaging Defect

    Zimmer is recalling 7 NexGen LPS Femoral Components because undersized foam inserts may allow the inner cavity to breach during shipping.

    Product
    NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0654-2018·2018-02-28

    Arrow Multi Lumen CVC Kit Recalled for Incorrect Springwire Guide

    Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.

    Product
    Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0679-2018·2018-02-28

    Vygon Recalls LifeGuard Huber Needles Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 396 units of LifeGuard Huber Needles because packaging adhesive gaps may compromise sterility.

    Product
    20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0495-2018·2018-02-28

    FDA Recalls Hydroxyprogesterone Caproate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Hydroxyprogesterone Caproate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2018·2018-02-28

    Medtronic CareLink iPro Software Recall for Time Conversion Error

    Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.

    Product
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0531-2018·2018-02-28

    Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls

    American Pharmaceutical Ingredients is recalling Ursodiol USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2018·2018-02-28

    Lidocaine USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Lidocaine USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2018·2018-02-28

    Lincomycin HCl USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Lincomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0535-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2018·2018-02-28

    Voluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues

    Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.

    Product
    Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0478-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0829-2018·2018-02-28

    Bob's Red Mill Organic Creamy Wheat Hot Cereal Recalled for Undeclared Wheat

    Bob's Red Mill is recalling Organic Creamy Wheat Hot Cereal because the back label incorrectly identifies the product as muffins, failing to declare wheat.

    Product
    Organic Creamy Wheat Hot Cereal, Item number 6097C244, Pack size: 24 oz bag, 4 bags in a case. UPC: 3997800992
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0487-2018·2018-02-28

    FDA Recalls Duloxetine HCl for Prescription Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Duloxetine HCl USP for prescription compounding due to a lack of stability data and controls to support expiration dates.

    Product
    Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2018·2018-02-28

    FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.

    Product
    Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.

    Product
    Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0539-2018·2018-02-28

    Fluticasone Propionate USP Recalled for Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Fluticasone propionate USP for prescription compounding due to a lack of stability data and controls to support expiration dates.

    Product
    Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0522-2018·2018-02-28

    Sumatriptan USP for Prescription Compounding Recalled Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Sumatriptan USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2018·2018-02-28

    Oxandrolone USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2018·2018-02-28

    Naltrexone HCl USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Naltrexone HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2018·2018-02-28

    FDA Recalls Diphenhydramine HCl Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned expiration date.

    Product
    Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

    Arrow International Inc is recalling 5,926 central venous catheterization kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0536-2018·2018-02-28

    Biotin USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2018·2018-02-28

    Ketoconazole USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Ketoconazole USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0525-2018·2018-02-28

    FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.

    Product
    Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0649-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2018·2018-02-28

    Arrow International Recalls Central Venous Catheters With Incorrect Guide

    Arrow International Inc. is recalling 5,926 ARROWg+ard Blue Plus Multi Lumen CVC kits that may contain the incorrect Springwire Guide.

    Product
    ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2018·2018-02-28

    Progesterone USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Progesterone USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

    Product
    Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2018·2018-02-28

    FDA Recalls Itraconazole USP for Prescription Compounding Due to Stability Data Issues

    American Pharmaceutical Ingredients LLC is recalling Itraconazole USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 483
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2018·2018-02-28

    FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues

    American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support expiration dates.

    Product
    Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2018·2018-02-28

    Baclofen USP Micronized Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Baclofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2018·2018-02-28

    Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

    Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0534-2018·2018-02-28

    Verapamil HCl USP Recalled for Missing Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Verapamil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.

    Product
    Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2018·2018-02-28

    Cyclobenzaprine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2018·2018-02-28

    FDA Recalls Estrone USP for Prescription Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding because it lacks stability data and controls to support its expiration dates.

    Product
    Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2018·2018-02-28

    FDA Recalls Testosterone Cypionate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Testosterone Cypionate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0680-2018·2018-02-28

    Vygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect

    Vygon is voluntarily recalling 300 units of CVC Tray Pediatrics because packaging adhesive gaps may compromise sterility.

    Product
    CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0496-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.

    Product
    Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2018·2018-02-28

    FDA Recalls Calcipotriene BP Due to Missing Stability Data

    American Pharmaceutical Ingredients is recalling Calcipotriene BP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2018·2018-02-28

    FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Testosterone Enanthate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

    Product
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2018·2018-02-28

    Phentolamine Mesylate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2018·2018-02-28

    Prilocaine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2018·2018-02-28

    Levocetirizine Dihydrochloride Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Levocetirizine Dihydrochloride for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Instruction and Injury Information

    Philips is recalling QCPR meters to inform users of correct pad placement and injuries associated with CPR performance.

    Product
    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2018·2018-02-28

    FDA Recalls Leucovorin Calcium Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Leucovorin Calcium USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Anastrozole USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Anastrozole USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.

    Product
    Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0492-2018·2018-02-28

    Fluconazole USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

    Product
    Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2018·2018-02-28

    FDA Recalls Testosterone USP Micronized for Prescription Compounding

    American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2018·2018-02-28

    Nandrolone Decanoate USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0494-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding

    American Pharmaceutical Ingredients LLC is recalling Gabapentin USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0664-2018·2018-02-28

    LivaNova Recalls Sorin Group Smart Perfusion Packs Due to Incorrect Expiration Date

    LivaNova USA is recalling 16 units of Sorin Group Smart Perfusion Pack E-Packs because they are labeled with incorrect expiration dates.

    Product
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0668-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling two units of Heliomolar Refill 20x0.25g 110T because the material was reported to be too soft and sticky, affecting handling.

    Product
    Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0667-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling

    Ivoclar Vivadent is recalling Heliomolar Refill units because complaints reported the material was too soft and sticky, causing unexpected handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0473-2018·2018-02-28

    Nostrum Recalls Calcium Acetate Capsules Due to Foreign Material Presence

    Nostrum Laboratories is recalling Calcium Acetate Capsules because foreign tablets or capsules were found in the product.

    Product
    Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0666-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling Heliomolar Refill units because the material was reported to be too soft and sticky, causing handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0665-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency

    Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 because complaints reported the material was too soft and sticky, causing unexpected handling during use.

    Product
    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·18V137000·2018-02-27

    Hyundai Recalls Sonata and Sonata Hybrid for Air Bag Defect

    Hyundai is recalling 2011-2013 Sonata and 2011-2012 Sonata Hybrid vehicles because the air bag control unit may short circuit, preventing safety systems from deploying in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA HYBRID, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V138000·2018-02-27

    Altec Recalls 2004-2005 Aerial Devices Due to Boom Failure Risk

    Altec Industries is recalling 2004-2005 aerial devices and elevator vehicles because the fiberglass upper boom may degrade and fail, increasing the risk of injury or death.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V135000·2018-02-27

    ACG Recalls 2016-2017 Moke Vehicles for Non-Laminated Windshields

    American Custom Golf Cars is recalling 2016-2017 Moke vehicles because some have non-laminated windshields that fail federal safety standards, increasing injury risk in crashes.

    Product
    ACG — ACG MOKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V130000·2018-02-22

    Toyota Recalls 2018 Sienna Vehicles Due to Wheel Cracking Risk

    Toyota is recalling 2018 Sienna vehicles because specific alloy wheels may crack from impact, potentially causing loss of vehicle control.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18725·2018-02-22

    Yamaha Recalls Golf Cars and PTVs Due to Brake Cable Failure Hazard

    Yamaha is recalling about 161,000 golf cars and personal transportation vehicles because brake cables can fail, posing a crash hazard. No injuries have been reported.

    Product
    Yamaha Golf Cars and Personal Transportation Vehicles (PTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18106·2018-02-22

    Monster Moto Recalls 212cc Mini Bikes Due to Fuel Leak Fire Hazard

    Monster Moto is recalling about 1,800 Classic 212cc mini bikes because the fuel tank venting system can leak gasoline, posing a fire hazard.

    Product
    Monster Moto Classic 212cc mini bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V131000·2018-02-22

    2017 Jeep Renegade Recall for Cracked Oil Pump Housing

    Chrysler is recalling 2017 Jeep Renegade vehicles with 2.4L engines due to a cracked oil pump housing that can cause engine stalling and increase crash risk.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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