The Recall Desk

Archive

July 2019 recalls

903 recalls were announced in July 2019.

What the numbers show

Critical
24
Severe
150
High
252
Moderate
463
Low
14

Of the 903 recalls this month scored against our rubric, 3% are Critical, 17% are Severe.

Which agencies issued them

601–700 of 903

  • ModerateFDA (Devices)·Z-1963-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2019·2019-07-24

    Roche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination

    Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.

    Product
    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1581-2019·2019-07-24

    Valley Processing Recalls Single Strength Apple Juice Due to Patulin

    Valley Processing, Inc. is recalling 11,504 gallons of single strength apple juice because patulin levels exceeded 50 ppb. The product was distributed in California.

    Product
    Single Strength Apple Juice shipped in 5700 gallon tanker. The tanker label is read in parts: "***SINGLE STRENGTH APPLE JUICE ***VALLEY PROCESSING INC. SUNNYSIDE, WA *** O/TKR LUDFORD'S INC ***PO #53018VP-8 *** BRIX: 11.5 MIN***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1970-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2019·2019-07-24

    Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time. Revised labeling and training are being offered.

    Product
    CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Hose/Drape Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2019·2019-07-24

    Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

    Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

    Product
    Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stab
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical pract
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1490-2019·2019-07-24

    Lupin Recalls Gatifloxacin Ophthalmic Solution Due to Missing Labels

    Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1974-2019·2019-07-24

    Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.

    Product
    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1551-2019·2019-07-24

    Wilton Chocolate Decorator Icing Recalled for Mold

    Wilton Brands is voluntarily recalling 15,032 units of Chocolate Decorator Icing due to mold. The product was distributed in 35 states.

    Product
    Wilton Chocolate decorator icing stiff consistency 16 oz plastic tub retail unit 6 or 12 retail units per wholesale unit
    Category
    Food
    Distribution
    37 states
  • LowFDA (Devices)·Z-1975-2019·2019-07-24

    Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.

    Product
    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V541000·2019-07-23

    BMW Recalls 2019 X5 and X7 Models for Loose Wheel Bolts

    BMW is recalling 2019 X5 xDrive50i and X7 xDrive40i vehicles because left-side wheel bolts may loosen, increasing the risk of a crash.

    Product
    BMW — BMW X7, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·076-2019·2019-07-20

    US Foods Recalls Raw Beef and Pork Due to Possible Contamination

    US Foods is recalling approximately 712 pounds of raw beef and pork products that may be contaminated due to a potential employee injury during production.

    Product
    US Foods Inc. — US Foods Recalls Raw Beef and Pork Products Due to Possible Product Contamination
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·19V538000·2019-07-19

    Hyundai Recalls Genesis G80 and G90 Vehicles for Oil Leak Fire Risk

    Hyundai is recalling 2018 Genesis G80 and 2017-2018 Genesis G90 vehicles because a loose seal may cause oil to leak onto the exhaust manifold, increasing fire risk.

    Product
    GENESIS — GENESIS G90, G80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E047000·2019-07-19

    MORryde Recalls Fifth Wheel Pin Boxes Due to Short Bolts

    MORryde is recalling certain You Turn and Orbital Rotating Pin boxes because they may have shorter bolts than required, increasing the risk of a crash.

    Product
    TRAILER HITCHES:FIFTH WHEEL ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E046000·2019-07-19

    MORryde Recalls Fifth Wheel Wedge Kits Due to Incorrect Bolts

    MORryde is recalling certain Orbital and You Turn Rubber Pin Box Wedge Kits because incorrect bolt lengths may prevent proper tightening, increasing crash risk.

    Product
    TRAILER HITCHES:FIFTH WHEEL ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V540000·2019-07-19

    Mercedes-Benz Recalls Vehicles for Radar Sensor Software Error

    Mercedes-Benz is recalling 2019-2020 vehicles because a software error in the radar sensor may impair Active Brake Assist, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS 450, C 300, E 450, E 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·075-2019·2019-07-18

    Koch Foods Recalls Breaded Chicken Bites for Undeclared Allergens

    Koch Foods is recalling approximately 743 pounds of breaded chicken bites because they contain undeclared soy, milk, and eggs.

    Product
    Koch Foods — Koch Foods Recalls Breaded Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1546-2019·2019-07-17

    Baumer Foods Recalls Mislabeled Worcestershire Sauce Sold as Soy Sauce

    Baumer Foods is recalling 10 FL OZ bottles of Worcestershire sauce mislabeled as soy sauce due to an undeclared allergen. The product was distributed to retail locations in six northeastern states.

    Product
    Soy Sauce, 10 FL OZ
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1483-2019·2019-07-17

    Riverpoint Pharmacy Recalls Chorionic Gonadotropin Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific vials of Chorionic Gonadotropin Injection due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1476-2019·2019-07-17

    Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Hydroxocobalamin 10 mg/mL Injection due to a lack of assurance of sterility. The product is distributed in Idaho and Washington.

    Product
    Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1477-2019·2019-07-17

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Methylcobalamin 1 mg/mL Injection vials due to a lack of assurance of sterility.

    Product
    Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1469-2019·2019-07-17

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    First Pharma Associates is recalling Testosterone Cypionate 150 mg/mL Injection due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·19V535000·2019-07-17

    Volkswagen Recalls 2015-2016 CC and Tiguan for Air Bag Defect

    Volkswagen is recalling 27,822 2015-2016 CC and Tiguan vehicles because a defective air bag control unit may cause air bags to fail or deploy unexpectedly.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1473-2019·2019-07-17

    Riverpoint Pharmacy Recalls Testosterone Cyp/Estradiol Cyp Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific vials of Testosterone Cyp/Estradiol Cyp Injection because of a lack of assurance of sterility.

    Product
    Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1480-2019·2019-07-17

    Riverpoint Pharmacy Recalls PAP/PHEN/PGE1 Injection Due to Sterility Concerns

    First Pharma Associates LLC dba Riverpoint Pharmacy is recalling specific lots of PAP/PHEN/PGE1 Injection due to a lack of assurance of sterility.

    Product
    PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1479-2019·2019-07-17

    Riverpoint Pharmacy Recalls PAP/PHEN/PGE1 Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific lots of PAP/PHEN/PGE1 Injection because the sterility of the product cannot be assured.

    Product
    PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1475-2019·2019-07-17

    Riverpoint Pharmacy Recalls Prostaglandin Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling Prostaglandin 20 mcg/mL/Procaine 0.1% Injection due to a lack of assurance of sterility.

    Product
    Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205 (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1472-2019·2019-07-17

    Testosterone Cypionate Injection Recalled for Sterility Assurance Concerns

    First Pharma Associates is recalling Testosterone Cypionate 100 mg/mL oil injections due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1458-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2019·2019-07-17

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2019·2019-07-17

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Methylcobalamin 10 mg/mL Injection vials due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1874-2019·2019-07-17

    Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk

    Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.

    Product
    HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1481-2019·2019-07-17

    FDA Recalls Riverpoint Pharmacy Injection Due to Sterility Concerns

    First Pharma Associates LLC dba Riverpoint Pharmacy is recalling PAP/PHEN/PGE1 Injection due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1484-2019·2019-07-17

    Glutathione Inhalation Solution Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling specific vials of Glutathione 100 mg/mL Inhalation Solution due to a lack of assurance of sterility.

    Product
    Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1459-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2019·2019-07-17

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Losartan Potassium 100 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1464-2019·2019-07-17

    Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity

    Golden State Medical Supply is recalling Losartan Potassium 50 mg tablets because a nitrosamine impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2019·2019-07-17

    Riverpoint Pharmacy Recalls PAP/PHEN/PGE1 Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific lots of PAP/PHEN/PGE1 Injection due to a lack of assurance of sterility.

    Product
    PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1465-2019·2019-07-17

    Losartan Potassium Tablets Recalled Due to NMBA Impurity Detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 100 mg tablets because an impurity called NMBA was detected in the active ingredient.

    Product
    Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1923-2019·2019-07-17

    Philips HeartStart MRx Recall Due to AC Power Module Failure Risk

    Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.

    Product
    Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2019·2019-07-17

    Losartan Potassium tablets recalled due to impurity detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2019·2019-07-17

    FDA Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    First Pharma Associates is recalling Hydroxyprogesterone Caproate 250 mg/mL injections due to a lack of assurance of sterility. The recall affects vials distributed in Idaho and Washington.

    Product
    Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1466-2019·2019-07-17

    Major Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Major Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2019·2019-07-17

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E045000·2019-07-17

    Reyco Fire Truck Front Suspension Recall for Shock Separation Risk

    Reyco is recalling Fire Truck Independent Front Suspensions because front shocks may separate and damage the steering gear, potentially causing a loss of power steering assist.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1532-2019·2019-07-17

    B.C. Frozen Foods Recalls Gordon CHOICE Whole Strawberries Due to Norovirus

    B.C. Frozen Foods is voluntarily recalling Gordon CHOICE Whole Strawberries due to a potential norovirus contamination. The recall affects 5lb bags distributed in the US and Canada.

    Product
    Gordon CHOICE Whole Strawberries; 5lb bags; UPC Code 93901 24463 5
    Category
    Food
    Distribution
    0 states
  • HighCPSC·19169·2019-07-17

    Bodum Bistro Toasters Recalled for Electric Shock Hazard

    Bodum is recalling Bistro Toasters because they can leak electric current at maximum temperature, posing a shock hazard. No U.S. injuries were reported, but eight shocks occurred in Canada.

    Product
    Bodum Bistro Toasters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V534000·2019-07-17

    Navistar Recalls 2020 IC CE School Buses Due to Electrical Overload

    Navistar is recalling 2020 IC CE school buses because an electrical overload in the Body Control Module may cause the engine to start unexpectedly, increasing injury risk during service.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1539-2019·2019-07-17

    Stagno's Bakery Recalls Wholesale Frozen Egg Bagel Dough for E. Coli Risk

    Stagno's Bakery is recalling 11 cases of wholesale frozen egg bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P011, Egg Bagel , Contains Wheat, Soy, Egg Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1536-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Blueberry Bagel Dough Due to E. Coli Risk

    Stagno's Bakery, Inc. is recalling 75 cases of frozen blueberry bagel dough because the product is potentially contaminated with E. Coli.

    Product
    Stagno's Bakery, Inc., P006, Blueberry Bagel , Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1547-2019·2019-07-17

    Riverside Foods Recalls Great Value Blackberries Due to Norovirus

    Riverside Foods is recalling Great Value Blackberries after an FDA test found norovirus in a random sample.

    Product
    Great Value Blackberries NET WT 16 OZ (1 LB) 454g bags DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 KEEP FROZEN UPC 0 78742 43101 7
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-1468-2019·2019-07-17

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Testosterone Cypionate 100 mg/mL injections due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1540-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Honey Wheat Bagel Dough for E. Coli Risk

    Stagno's Bakery is recalling 125 cases of frozen Honey Wheat Bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P014, Honey Wheat Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1770-2019·2019-07-17

    Becton Dickinson Recalls Alaris Pump Infusion Sets Due to Occlusion Defect

    Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.

    Product
    Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1537-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Bagel Dough for E. Coli Contamination

    Stagno's Bakery, Inc. is recalling 69 cases of frozen chocolate chip bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P009, Choc Chip Bagel, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1541-2019·2019-07-17

    Stagno's Bakery Recalls Jalapeno Bagel Dough Due to E. Coli Risk

    Stagno's Bakery is recalling 55 cases of wholesale frozen jalapeno bagel dough because it is potentially contaminated with E. Coli.

    Product
    Stagno's Bakery, Inc., P018, Jalapeno Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1545-2019·2019-07-17

    Stagno's Bakery Recalls Wholesale Frozen Grain Bagel Dough for E. Coli

    Stagno's Bakery, Inc. is recalling 57 cases of wholesale frozen grain bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P005, Grain Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·19V533000·2019-07-17

    Porsche Recalls 2016-2017 Models for Air Bag Control Module Defect

    Porsche is recalling 2016-2017 911, Boxster, Cayman, and Panamera vehicles because a defective capacitor in the air bag control unit may cause air bags to fail or deploy unexpectedly.

    Product
    PORSCHE — PORSCHE 718 BOXSTER, PANAMERA, 911, 718 CAYMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1471-2019·2019-07-17

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Testosterone Cypionate 200 mg/mL injections due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-1950-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.

    Product
    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Food)·F-1548-2019·2019-07-17

    Riverside Foods Recalls Tipton Grove Frozen Mixed Berries Due to Norovirus

    Riverside Foods is recalling Tipton Grove Frozen Mixed Berries after an FDA test found norovirus in a random sample.

    Product
    Tipton Grove Frozen Mixed Berries NET WT 12 OZ (340g) bags DISTRIBUTED BY: Save-A-Lot KEEP FROZEN UPC 0 51933 34784 7
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1549-2019·2019-07-17

    Ziba Nut Edamame Green Beans Recalled for Undeclared Soy Allergen

    Ziba Nut Incorporated is recalling salted and roasted edamame green beans because the product does not declare soy on the label.

    Product
    OU Kosher Salted and Roasted Edamame Green Beans (Regular Salt), Packing: 2x11 lbs, Net WT: 22lbs, Product Of China
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1959-2019·2019-07-17

    Applied Medical Recalls Kii Fios First Entry Devices for Sterility Concerns

    Applied Medical Resources Corp is recalling Kii Fios First Entry devices because they may not have met sterility requirements, potentially exposing patients to infectious agents.

    Product
    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1470-2019·2019-07-17

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Testosterone Cypionate 200 mg/mL injections due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1542-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Bagel Dough Due to E. Coli Contamination

    Stagno's Bakery, Inc. is recalling 1,029 cases of wholesale frozen plain bagel dough because the product is potentially contaminated with E. Coli.

    Product
    Stagno's Bakery, Inc., P001, Plain Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1485-2019·2019-07-17

    Riverpoint Pharmacy Recalls Serum Tears 20% Eye Drops Due to Sterility Concerns

    First Pharma Associates is recalling specific lots of Serum Tears 20% Eye Drops in Idaho and Washington due to a lack of assurance of sterility.

    Product
    Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1457-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1544-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Spinach Garlic Bagel Dough for E. Coli Risk

    Stagno's Bakery is recalling 54 cases of frozen spinach garlic bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P016, Spinach Garlic Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1543-2019·2019-07-17

    Stagno's Bakery Recalls Frozen Pumpernickel Bagel Dough for E. Coli Risk

    Stagno's Bakery is recalling 61 cases of frozen pumpernickel bagel dough due to potential E. Coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P015, Pumpernickel Bagel , Contains Wheat, Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1538-2019·2019-07-17

    Stagno's Bakery Recalls Wholesale Frozen Cranberry Raisin Bagel Dough

    Stagno's Bakery is recalling 130 cases of frozen cranberry raisin bagel dough due to potential E. coli contamination. The product was shipped to one consignee in Schenectady, NY.

    Product
    Stagno's Bakery, Inc., P019, Cranberry Raisin Bagel ,Contains: Wheat and Soy, Case 32lbs. Count per Case 120 of wholesale frozen bagel dough / bulk . Keep Frozen
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1533-2019·2019-07-17

    Reily Foods Recalls Blue Plate Light Olive Oil Mayonnaise Due to Yeast

    Reily Foods is recalling Blue Plate Light Olive Oil Mayonnaise because yeast caused gas formation, leading to bloated bottles and mayonnaise release.

    Product
    Blue Plate Light Olive Oil Mayonnaise 30oz / 18oz, PET jars and PET squeeze bottles
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1957-2019·2019-07-17

    Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging

    Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.

    Product
    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2019·2019-07-17

    Canon Radrex-i X-Ray System Software Malfunction Recall

    Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

    Product
    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2019·2019-07-17

    GE Healthcare Recalls Panda Infant Radiant Warmers Due to Bedside Panel Cracking

    GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them instead of the designated handles.

    Product
    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2019·2019-07-17

    GE Healthcare Recalls Giraffe Infant Radiant Warmers Due to Panel Cracking

    GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.

    Product
    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1535-2019·2019-07-17

    Hallmark Fisheries Recalls IQF Shrimp Meat Due to Foreign Object

    California Shellfish, Inc. dba Hallmark Fisheries is recalling Ocean Supreme and Yaquina Bay IQF shrimp meat because a foreign object was found inside the product packaging.

    Product
    Ocean Supreme and Yaquina Bay IQF shrimp meat, product of USA wild caught, cooked and peeled, 5 lb. bag, 4/5 lb. bags per box, net wt. 20#. The BAG label is read in parts: "***Ocean Supreme *** Cooked & Peeled I.Q.F SHRIMP MEAT ***Ingredients: Shrimp Meat and Salt ***Net Wt. 5
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1949-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1955-2019·2019-07-17

    MAHURKAR and Argyle acute hemodialysis catheters recalled for inaccurate priming volume labels

    COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.

    Product
    MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 881714900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1952-2019·2019-07-17

    Rinovum Recalls Revive Reusable Bladder Support Due to Structural Defect

    Rinovum Women's Health is recalling the Revive Reusable Bladder Support because the device may split or crack during its intended use life.

    Product
    Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19168·2019-07-16

    K2 Sports Recalls VO2 S Inline Skates Due to Fall Hazard

    K2 Sports is recalling VO2 S inline skates because the axle can loosen or break, causing wheels to separate and posing a fall hazard. No injuries have been reported.

    Product
    VO2 S inline skates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19167·2019-07-16

    VIVO Recalls Speaker Wall Mounts Due to Fall and Injury Hazards

    VIVO is recalling MOUNT-PLAY5 speaker wall mounts because the front ledge can loosen, causing speakers to fall. No injuries have been reported.

    Product
    VIVO MOUNT-PLAY5 speaker wall mounts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19762·2019-07-16

    Majestic Pure Wintergreen Oil Recalled for Non-Child-Resistant Packaging

    Epic Business Services is recalling Majestic Pure Wintergreen Oil because the packaging fails to meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Majestic Pure Wintergreen Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V530000·2019-07-14

    BYD Recalls 2019 C8M Buses Due to Glass Roof Hatch Shattering Risk

    BYD is recalling 2019 C8M buses because temperature and vibration stresses may cause the tempered glass roof escape hatches to shatter, potentially injuring passengers.

    Product
    BYD — BYD C8M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·074-2019·2019-07-14

    Fieldsource Recalls Marinated Beef and Chicken Due to Undeclared Wheat

    Fieldsource Food Systems is recalling marinated beef and chicken cubes because they contain undeclared wheat, a known allergen.

    Product
    Fieldsource Food Systems, Inc. — Fieldsource Food Systems, Inc. Recalls Beef and Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·073-2019·2019-07-13

    Ada Valley Recalls Raw Ground Beef Meatloaf Due to Metal Bits

    Ada Valley Gourmet Foods is recalling raw ground beef meatloaf products that may contain broken metal bits. The products were shipped to hospitals in Arizona, California, and Nevada.

    Product
    Ada Valley Gourmet Foods — Ada Valley Gourmet Foods, Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states

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