The Recall Desk

Archive

December 2018 recalls

451 recalls were announced in December 2018.

What the numbers show

Critical
15
Severe
151
High
174
Moderate
94
Low
17

Of the 451 recalls this month scored against our rubric, 3% are Critical, 33% are Severe.

Which agencies issued them

101–200 of 451

  • ModerateFDA (Devices)·Z-0637-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0621-2019·2018-12-26

    Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance

    Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.

    Product
    Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0611-2019·2018-12-26

    Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.

    Product
    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2019·2018-12-26

    Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance

    Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.

    Product
    Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0640-2019·2018-12-26

    Advanced Instruments Recalls GloCyte RBC Reagent Due to QC Failure

    Advanced Instruments, LLC is recalling GloCyte RBC Reagent because high fluorescent counts cause quality control checks to fail, preventing patient sample testing.

    Product
    GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging lists incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2019·2018-12-26

    KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code

    KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0656-2019·2018-12-26

    COVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve

    COVIDIEN LLC is recalling 32,071 units of 8Fr Argyle Suction Catheter Kits with Chimney Valve, Model 36826, because they were distributed while subject to importation refusal.

    Product
    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0632-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.

    Product
    VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0773-2019·2018-12-26

    Luckyberry Cold-Pressed Juice Recalled Due to Violation of Juice HACCP Regulations

    Luckyberry is recalling certain unpasteurized cold-pressed juice products because they were manufactured and distributed in violation of juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Spicy Watermelon, Watermelon, Red Beet, Lime, Mint, Green Apple, Jalepeno, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0631-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0655-2019·2018-12-26

    Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding

    Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.

    Product
    RT-5100 Refractor, a component of the Epic-5100 System.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0642-2019·2018-12-26

    Zimmer Biomet Compress System Surgical Technique Correction Recall

    Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.

    Product
    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0348-2019·2018-12-26

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.

    Product
    NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0342-2019·2018-12-26

    CBI Laboratories Recalls Subpotent Options Rx Sunscreen Tubes

    CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.

    Product
    Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V928000·2018-12-21

    Prevost Recalls Buses Due to Draglink Fracture Risk

    Prevost is recalling 676 buses because a steering component may fracture, causing a loss of steering and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45, XLII-45, XL-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V930000·2018-12-21

    Thomas Built Saf-T-Liner C2 School Bus Recall for Electrical Overload

    Daimler Trucks is recalling 2019-2020 Thomas Built Saf-T-Liner C2 school buses because an electrical overload may cause the engine to shut down, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V924000·2018-12-21

    Collins Recalls 2018 Buses Due to Improperly Tightened Seat Bolts

    Collins Bus Corporation is recalling 2018 SH, DH, P24, T22, T24, and TH buses because seat bolts may not be properly tightened, increasing injury risk in a crash.

    Product
    COLLINS — COLLINS DH, TH, T22, P24
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·124-2018·2018-12-21

    Jennie-O Recalls Raw Ground Turkey Due to Salmonella Reading Contamination

    Jennie-O is recalling approximately 164,210 pounds of raw ground turkey products produced in October 2018 due to possible Salmonella Reading contamination.

    Product
    Jennie-O Turkey Store — Jennie-O Turkey Store Sales, Inc. Recalls Raw Ground Turkey Products due to Possible Salmonella Reading Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V929000·2018-12-21

    Thomas Built Buses Recalls Saf-T-Liner C2 for Electrical Overload Risk

    Daimler Trucks North America is recalling 2019-2020 Thomas Built Saf-T-Liner C2 buses because an electrical overload may cause the engine to shut down, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V927000·2018-12-21

    Harley-Davidson Recalls Street Motorcycles Due to Brake Caliper Corrosion

    Harley-Davidson is recalling 2016-2019 Street 500, 750, and 750A motorcycles because brake calipers may corrode internally, causing increased brake drag and a higher risk of crash.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG500, XG750A, XG750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V921000·2018-12-20

    Honda Recalls 2017-2018 Clarity Fuel Cell for Power Loss Risk

    Honda is recalling 2017-2018 Clarity Fuel Cell vehicles previously repaired under recall 18V-068 because incomplete software updates may cause partial or complete power loss.

    Product
    HONDA — HONDA CLARITY FUEL CELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V920000·2018-12-20

    Custom Truck and Body Works Recalls Ambulances and Trucks with Faulty Brake Lights

    Custom Truck and Body Works is recalling 2017-2019 ambulances and trucks because Whelen accessory brake lights may illuminate without the brake pedal being pressed.

    Product
    CUSTOM TRUCK & BODY WORKS — CUSTOM TRUCK & BODY WORKS TANKER, TYPE 2 AMBULANCE, TYPE 3 AMBULANCE, RESCUE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19057·2018-12-20

    Navien Recalls Tankless Water Heaters and Boilers Due to Carbon Monoxide Risk

    Navien is recalling specific tankless water heaters and boilers converted to propane due to a risk of excessive carbon monoxide production. No injuries have been reported.

    Product
    Navien condensing tankless water heaters and combination boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V919000·2018-12-20

    Toyne Fire Apparatus Recalled for Brake Light Wiring Defect

    Toyne Inc. is recalling 2017-2018 Fire Apparatus trucks because Whelen accessory brake lights may illuminate falsely, potentially confusing other drivers.

    Product
    TOYNE — TOYNE FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V917000·2018-12-20

    2019 Jeep Cherokee Recall for Instrument Cluster Failure

    Chrysler is recalling 2019 Jeep Cherokee vehicles because the instrument cluster may fail, preventing warning chimes and gauges from activating, which increases crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0718-2019·2018-12-19

    Quaker Recalls Cap'n Crunch Peanut Butter Crunch Cereal Due to Salmonella

    Quaker Manufacturing is recalling specific lots of Cap'n Crunch's Peanut Butter Crunch Cereal because the product tested positive for Salmonella.

    Product
    Cap'n Crunch's Peanut Butter Crunch Cereal packaged in 17.1 ounce and 16.5 ounce cardboard boxes. Distributed by The Quaker Oats Company, Chicago IL
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0309-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V914000·2018-12-19

    Thomas Built Buses Recalls School Buses for Loose Steering Bolts

    Daimler Trucks is recalling 2018-2019 Thomas Built Saf-T-Liner school buses because loose steering tie rod arm bolts may separate, affecting steering and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0716-2019·2018-12-19

    Baraka Mild Curry Powder Recalled for High Lead Levels

    U.B.C. Food Distributors is voluntarily recalling Baraka Mild Curry Powder due to high levels of lead found in the product.

    Product
    Baraka Mild Curry Powder packed in 7 oz. Plastic Jar
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0735-2019·2018-12-19

    K & T Oriental Imports Recalls Salmon Fillets for Listeria Risk

    K & T Oriental Imports Inc. is recalling 3,094 kgs of salmon fillets in Texas and New Mexico due to potential Listeria monocytogenes contamination.

    Product
    Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which were stored inside a temperature controlled cooler
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0301-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan Tablets because FDA testing found traces of the NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets 5 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0327-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan 320 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0318-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0312-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0316-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0322-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V907000·2018-12-19

    Kia Recalls Optima, Sportage, and Sorento for Fuel Leak Risk

    Kia is recalling 2011-2018 Optima, Sportage, and Sorento vehicles that had previous engine replacements due to a potential fuel pipe defect that could cause a leak and fire.

    Product
    KIA — KIA OPTIMA, SPORTAGE, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0304-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0329-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0321-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0326-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA). The product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0311-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V899000·2018-12-19

    General Motors Recalls 2019 Cadillac XTS for Front Seat Belt Defect

    General Motors is recalling 2019 Cadillac XTS vehicles because a missing rivet in the front seat belt buckle may allow it to separate during a crash, increasing injury risk.

    Product
    CADILLAC — CADILLAC XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2019·2018-12-19

    Arjo Passive Clip Sling Recalled for Material Breakage Risk

    ArjoHuntleigh is recalling 10 units of Passive Clip Slings because the material may break during patient transfers, posing a risk of falls and serious injury.

    Product
    ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0325-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to Trace NDEA Impurity

    Mylan is recalling specific lots of Valsartan 80 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0310-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2019·2018-12-19

    GE Healthcare Recalls Discovery NM/CT 670 DR Due to Electrical Hazard

    GE Healthcare is recalling four Discovery NM/CT 670 DR units because incorrect wiring of safety switches may prevent the system from shutting off power, creating an electrical hazard.

    Product
    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and…
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0715-2019·2018-12-19

    Baraka Hot Curry Powder Recalled for High Lead Levels

    U.B.C. Food Distributors is voluntarily recalling Baraka Hot Curry Powder in 7 oz plastic jars due to high levels of lead.

    Product
    Baraka Hot Curry Powder packed in 7 OZ Plastic Jar
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0308-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific bottles of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0330-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Laboratories is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0320-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0332-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0300-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0324-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0307-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan Tablets because FDA testing found traces of NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0581-2019·2018-12-19

    Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0331-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·18V905000·2018-12-19

    Mercedes-Benz Recalls 2018-2019 GLC63 Models for Air Bag Delay

    Mercedes-Benz is recalling 2018-2019 GLC63 and GLC63S vehicles because the frontal air bag may deploy late for unbelted passengers, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63S, AMG GLC63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·18V904000·2018-12-19

    Volkswagen Recalls Atlas, Jetta, and Golf for Rear Spring Fracture Risk

    Volkswagen is recalling 2018-2019 Atlas, 2015 Golf SportWagen, and 2019 Jetta vehicles because rear coil springs may fracture, potentially causing loss of control.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, JETTA, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V910000·2018-12-19

    Mercedes-Benz Recalls S-Class Vehicles for Steering Assist Malfunction

    Mercedes-Benz is recalling 2018-2019 S-Class vehicles because the hands-off detection system may fail, keeping steering assist active without driver input.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, S 450, S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2019·2018-12-19

    Feast Mode Garlic Beer Seasoning Recalled for Gluten Free Mislabeling

    Feast Mode Blending & Filling is recalling 5,000 units of Garlic Beer Seasoning because the product is mislabeled as 'Gluten Free'.

    Product
    Feast Mode Flavors Garlic Beer Seasoning, Nt. Wt. 5 oz, plastic bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V918000·2018-12-19

    BMW Recalls 2019 X5 Models for Missing Air Bag Warning Labels

    BMW is recalling 2019 X5 xDrive40i and xDrive50i vehicles because the sun visors may lack required air bag warning labels, increasing injury risk in crashes.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2019·2018-12-19

    Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure

    Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.

    Product
    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
    Category
    Medical Device
    Distribution
    44 states
  • HighNHTSA·18V912000·2018-12-19

    Mercedes-Benz Recalls 2018-2019 GLA 250 Models for Sunroof Leak

    Mercedes-Benz is recalling 2018-2019 GLA 250 vehicles because sunroof bonding may allow water leaks that could prevent the window air bag from deploying.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2019·2018-12-19

    GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk

    GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0703-2019·2018-12-19

    Schwan's Sea Salt Caramel Cashew Ice Cream Recalled for Glass Contamination

    Schwan's is recalling Sea Salt Caramel Cashew Ice Cream due to potential glass contamination. Consumers should check production codes and stop using the product.

    Product
    Schwan's Sea Salt Carmel Cashew Ice Cream (#206). Net Wt 56 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2019·2018-12-19

    GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

    GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2018.