The Recall Desk

Archive

April 2019 recalls

516 recalls were announced in April 2019.

What the numbers show

Critical
10
Severe
187
High
163
Moderate
133
Low
23

Of the 516 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

201–300 of 516

  • SevereNHTSA·19V312000·2019-04-18

    GM Recalls 2017-2019 Chevrolet Trax for Front Suspension Weld Defect

    General Motors is recalling 2017-2019 Chevrolet Trax vehicles because improperly welded front lower-control arm joints may break, causing partial separation and increased crash risk.

    Product
    CHEVROLET — CHEVROLET TRAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V314000·2019-04-18

    Mercedes-Benz Recalls 2019 A 220 Vehicles Due to Brake Pedal Welding Defect

    Mercedes-Benz is recalling 2019 A 220 and A 220 4MATIC vehicles because improper welding may cause the pedal plate to bend, impairing brake pedal operation and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ A 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V315000·2019-04-18

    Honda Recalls 2017-2018 Clarity Fuel Cell Vehicles for Water Pump Defect

    Honda is recalling 2017-2018 Clarity Fuel Cell vehicles because internal corrosion may cause the water pump to fail, potentially leading to a vehicle stall and increased crash risk.

    Product
    HONDA — HONDA CLARITY FUEL CELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19107·2019-04-18

    Tekno Recalls Tuff Smoke-Less Grills Due to Fire and Burn Hazards

    Tekno Products is recalling Tuff smoke-less grills because they can overheat, posing fire and burn hazards. Consumers should stop using the grills and return them for a refund.

    Product
    Tuff smoke-less grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V316000·2019-04-18

    Nissan Recalls 2019 Altima Vehicles Due to Fuel Pump Lock Ring Defect

    Nissan is recalling 2019 Altima vehicles with front-wheel drive and 2.5-liter engines because a fuel pump lock ring may not be fully engaged, potentially causing a fuel leak and fire risk.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V313000·2019-04-18

    MobilityTrans Recalls Modified Ford and Ram Vans with Defective Foldaway Seats

    Mobility Transportation Services is recalling modified Ford and Ram vans because foldaway seats may not stay locked during a crash, increasing injury risk.

    Product
    FORD — FORD, RAM, MOBILITY SPECIALISTS E-350, E-250, PROMASTER, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19108·2019-04-18

    Target Recalls Wooden Toy Vehicles Due to Choking Hazard

    Target is recalling Bullseye's Playground wooden toy vehicles because wheels can detach, posing a choking hazard to children.

    Product
    Bullseye's Playground wooden toy vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V309000·2019-04-18

    2019 Mercedes-Benz Sprinter Recalled for High-Beam Software Error

    Daimler Vans USA is recalling 2019 Mercedes-Benz Sprinter vans because a software error may prevent drivers from turning off high beams, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19739·2019-04-18

    RH Recalls Callum Canopy Beds Due to Falling Rail Injury Hazard

    RH is recalling Callum Canopy Beds because horizontal canopy rails can detach and fall. No injuries have been reported, but consumers should stop using the beds until repaired.

    Product
    Callum Canopy Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1135-2019·2019-04-17

    FDA Recalls Leopard Miracle Honey Containing Undeclared Sildenafil

    USA LESS Inc. is recalling Leopard Miracle Honey because it contains undeclared sildenafil, an unapproved drug for erectile dysfunction.

    Product
    LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1097-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Health Solutions Pharmacy Center is recalling compounded Papaverine-Phentolamine-PGE1 injectables because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V308000·2019-04-17

    Volvo Recalls 2016 XC90 Vehicles for Coolant Hose Fire Risk

    Volvo is recalling 2016 XC90 vehicles because a coolant hose may crack and leak, potentially causing a fire in the catalytic converter area.

    Product
    VOLVO — VOLVO XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1091-2019·2019-04-17

    FDA Recalls Compounded PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling PGE1 40 mcg/ml injectable vials because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1119-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: To
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1086-2019·2019-04-17

    FDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions

    The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.

    Product
    SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1123-2019·2019-04-17

    Encore Medical Recalls Exprt Precision System Hip Implant Components

    Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.

    Product
    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Drugs)·D-1101-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Health Solutions Pharmacy Center is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1116-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 100 mg, because FDA testing found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridg
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1106-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling a compounded injectable drug because FDA inspectors observed insanitary conditions during its compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1088-2019·2019-04-17

    Professional Compounding Pharmacy Recalls Acetyl-L-Cysteine Eye Drops Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling Acetyl-L-Cysteine 10% eye drops because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1094-2019·2019-04-17

    Professional Compounding Pharmacy Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1117-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: T
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1115-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 All
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1092-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine Injectable Due to Insanitary Conditions

    FDA is recalling compounded papaverine-phentolamine injectable due to insanitary conditions observed during compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1095-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 injectable because FDA inspectors observed insanitary conditions during the compounding process.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1099-2019·2019-04-17

    FDA Recalls Papaverine-Phentolamine Injectable Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling Papaverine-Phentolamine 15-0.5mg/mL injectable vials because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1111-2019·2019-04-17

    McDaniel Life-Line Recalls Indian Herb Paste Due to Unapproved New Drug Status

    McDaniel Life-Line LLC is voluntarily recalling 150 vials of Indian Herb Paste because the product is an unapproved new drug. The recall covers distribution in the US, Italy, Australia, Canada, and Poland.

    Product
    Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V311000·2019-04-17

    Hyundai Recalls 2019 Veloster Vehicles Due to Door Latch Defect

    Hyundai is recalling 12,438 2019 Veloster vehicles because the driver's door latch can fail in a side impact crash, potentially allowing the door to open.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V304000·2019-04-17

    Spartan Recalls 2019 Utilimaster Truck Bodies Due to Electrical Fire Risk

    Spartan Motors is recalling 2019 Utilimaster Truck Bodies because undersized wires may overheat, melt, and cause an unexpected engine shutdown, increasing crash risk.

    Product
    UTILIMASTER — UTILIMASTER TRUCK BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1273-2019·2019-04-17

    Almark Foods Recalls Hard-Boiled Eggs Due to Listeria Test Results

    Almark Foods is recalling 20-pound pails of Nic's Peeled Pearls hard-boiled eggs after FDA notified the firm of positive Listeria monocytogenes test results.

    Product
    Nic's Peeled Pearls 20lb. Salad Grade Hard-Boiled Eggs NET WT. WHEN PACKED 20lbs Manufactured By: Almark Foods Gainesville, GA 30504 1.800.849.EGGS
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1248-2019·2019-04-17

    Aurobindo Recalls MARBETA L KIT Vials Due to Particulate Matter

    Aurobindo Pharma USA Inc. is recalling 88,600 vials of MARBETA L KIT because one vial was found to contain a hair.

    Product
    MARBETA L KIT — MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1109-2019·2019-04-17

    FDA Recalls Compounded Papaverine Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded papaverine-phentolamine-PGE1 injectable due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1093-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    The FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable products from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1110-2019·2019-04-17

    FDA Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling a specific lot of Papaverine-Phentolamine-PGE1 injectable because FDA inspectors found insanitary conditions during the compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1104-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1081-2019·2019-04-17

    RemedyRepack Recalls Losartan 50mg Tablets Due to Impurity

    RemedyRepack Inc. is recalling Losartan 50mg tablets because trace amounts of an unexpected impurity, NMBA, were detected in the active ingredient.

    Product
    Losartan 50mg Tablet, 30 count each blister card.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1108-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1105-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Health Solutions Pharmacy Center is recalling compounded papaverine-phenolamine-PGE1 injectable vials because FDA inspectors observed insanitary conditions during the compounding process.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1090-2019·2019-04-17

    FDA Recalls Compounded Penile Injection Drugs Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded papaverine-phenolamine-PGE1 injections due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1096-2019·2019-04-17

    FDA Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Compounding Conditions

    FDA is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1118-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1114-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, because FDA labs found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1083-2019·2019-04-17

    Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity

    Pharma Pac is recalling Losartan Potassium 100 mg tablets because traces of a nitrosamine impurity were found in the active ingredient.

    Product
    Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1115-2019·2019-04-17

    Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks

    Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.

    Product
    Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2019·2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potenti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2019·2019-04-17

    Procept Biorobotics Recalls AquaBeam Handpieces Due to Potential Internal Leaks

    Procept Biorobotics is recalling 214 AquaBeam Handpieces because a micro-crack in a weld joint may cause an internal leak, potentially delaying or preventing the completion of medical procedures.

    Product
    AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19737·2019-04-17

    MTD Recalls Craftsman M350 Lawn Mowers Due to Injury Hazard

    MTD is recalling about 5,000 Craftsman M350 walk-behind lawn mowers sold at Lowe's because sharp objects can pierce the collecting bag and strike users or bystanders.

    Product
    Craftsman M350 walk-behind lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1120-2019·2019-04-17

    Glenmark Recalls Pravastatin Sodium Tablets Due to Foreign Tablet Presence

    Glenmark Pharmaceuticals is recalling 2,076 bottles of Pravastatin Sodium 20 mg tablets because a foreign tablet was found in the product.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V307000·2019-04-17

    Livin' Lite Recalls Trailers With Blocked Emergency Exit Windows

    Livin' Lite is recalling 2013-2017 Camplite and 2014-2017 Bearcat trailers because a manual awning arm may block an exit window, increasing injury risk during emergencies.

    Product
    LIVIN' LITE — LIVIN' LITE, LIVIN LITE CAMPLITE, BEARCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1107-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable vials from Professional Compounding Pharmacy due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1240-2019·2019-04-17

    Lemon Berry Scone Recalled for Undeclared Milk Allergen

    Thomas Hammer Coffee Roasters is recalling Lemon Berry Scones because the label declared butter but failed to declare milk.

    Product
    Lemon Berry Scone
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1300-2019·2019-04-17

    Theo Chocolate Sea Salt 70% Dark Chocolate Bars Recalled for Undeclared Milk

    Theo Chocolate is recalling Sea Salt 70% Dark Chocolate bars due to undeclared milk. The product was distributed nationwide.

    Product
    Sea Salt 70% Dark Chocolate 3 oz. bars, wrapped in foil and paper wrapper, brand Theo Chocolate, UPC 8 74492 00325 8. The Sea Salt 70% Dark Chocolate 3 oz. bar's label is read in part: "***Sea Salt 70% Dark Chocolate *** Ingredients: Cocoa Beans, Cane Sugar, Sea Salt, Ground V
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1276-2019·2019-04-17

    Trader Joe's Natural Creamer Recalled for Undeclared Milk Allergen

    Good Karma Foods is recalling Trader Joe's Natural Creamer - Vanilla because the product contains milk but the label does not list it as an ingredient.

    Product
    PL Trader Joe Natural Creamer - Vanilla 12/32oz, Plastic bottle, Distributed by Good Karma Foods, Inc. with manufacturing at Shamrock Foods at Phoenix, AZ., Keep refrigerated
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2019·2019-04-17

    DePuy CORAIL AMT High Offset Neck Segment Recall for Potential Debris

    DePuy Orthopaedics is recalling CORAIL AMT High Offset Neck Segments because debris or material may be found behind the O-rings.

    Product
    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2019·2019-04-17

    DePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments

    DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.

    Product
    CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1238-2019·2019-04-17

    Thomas Hammer Coffee Roasters Recalls Blueberry Bread for Undeclared Egg

    Thomas Hammer Coffee Roasters is recalling 15 loaves of Blueberry Bread sold in Idaho and Washington due to undeclared egg.

    Product
    Blueberry Bread was sold as slices wrapped individually in food grade pastry bags, 3.7 oz net weight at retail shops.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1120-2019·2019-04-17

    Becton Dickinson Recalls Gravity IV Sets Due to Kinked Tubing

    Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.

    Product
    Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1103-2019·2019-04-17

    Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results

    Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V305000·2019-04-17

    Spencer Fire Trucks Recalled for Brake Light Wiring Defect

    Spencer Manufacturing is recalling certain 2017-2019 fire trucks because Whelen accessory brake lights may illuminate without the brake pedal being pressed.

    Product
    SPENCER — SPENCER FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1087-2019·2019-04-17

    Dexamethasone Eye Drops Recalled Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling 12 prescriptions of Dexamethasone eye drops due to insanitary conditions observed during compounding.

    Product
    DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1098-2019·2019-04-17

    FDA Recalls PGE1-Lidocaine Injectable Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling PGE1-Lidocaine injectable products because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1113-2019·2019-04-17

    Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software

    Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.

    Product
    syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2019·2019-04-17

    BD Blood Collection Assembly Recalled for Luer Breakage Risk

    Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.

    Product
    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1099-2019·2019-04-17

    LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria

    LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.

    Product
    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-1112-2019·2019-04-17

    FDA Recalls Life-Line Catalytic Activated Energy Water as Unapproved New Drug

    McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water because it is an unapproved new drug. The product was distributed in the US and several international countries.

    Product
    Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2019·2019-04-17

    Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks

    Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.

    Product
    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2019·2019-04-17

    Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2019·2019-04-17

    Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk

    Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.

    Product
    syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2019·2019-04-17

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

    Product
    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2019·2019-04-17

    Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues

    Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: 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 licens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2019·2019-04-17

    DePuy CORAIL Neck Trials Recalled for Potential Debris Behind O-rings

    DePuy Orthopaedics is recalling CORAIL AMT Standard Offset Neck Segments because debris or material may be found behind the O-rings. These surgical instruments are used in hip arthroplasty.

    Product
    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1089-2019·2019-04-17

    FDA Recalls Hydroxyprogesterone Caproate Injectable Due to Compounding Conditions

    Professional Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1108-2019·2019-04-17

    Conformis Recalls Two iTotal CR Total Knee Replacement Systems

    Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.

    Product
    iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disabil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1250-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 5,000 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A84759 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1124-2019·2019-04-17

    Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues

    Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1111-2019·2019-04-17

    Beaver Xstar Slit Knife Recalled for Size Mismatch Labeling

    Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.

    Product
    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1248-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 40,250 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A81225 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1089-2019·2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1247-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 12,800 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A80261 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Food)·F-1251-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 2,750 lbs of commercial breader batter that may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A85608 BATTER MX X3; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Food)·F-1274-2019·2019-04-17

    Impossible Foods Bulk Plant-Based Ground Beef Recalled for Plastic Contamination

    Impossible Foods is recalling 5 lb. bulk plant-based ground beef packs due to a piece of plastic found in the product.

    Product
    Impossible Foods Bulk, 5 lb. vacuum sealed plastic-pack. Keep Frozen; This is a plant product that is looks like and is used like ground beef. UPC: (01) 00816697020036; Item # 60-00010
    Category
    Food
    Distribution
    7 states

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