The Recall Desk

Archive

November 2014 recalls

908 recalls were announced in November 2014.

What the numbers show

Critical
20
Severe
183
High
251
Moderate
429
Low
25

Of the 908 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

201–300 of 908

  • HighNHTSA·14V736000·2014-11-18

    Ford Recalls Fusion Models Due to Key Removal Safety Defect

    Ford is recalling 2014-2015 Fusion, Fusion Hybrid, and Fusion Energi vehicles because the key may be removed while the transmission is not in Park, increasing the risk of rollaway.

    Product
    FORD — FORD FUSION, FUSION HYBRID, FUSION ENERGI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V734000·2014-11-17

    Fleetwood Bounder Classic Recalled for Loose Grab Bar Risk

    Allied Recreation Group is recalling 2014-2015 Fleetwood Bounder Classic RVs because a grab bar may pull loose, increasing injury risk.

    Product
    FLEETWOOD — FLEETWOOD BOUNDER CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E078000·2014-11-17

    Carefree Latitude Awnings Recalled for Defective Screws on Motorhomes

    Carefree is recalling Latitude Awnings styles GX and G installed on motorhomes due to screws that may not meet specifications, posing a risk of the awning falling.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·079-2014·2014-11-15

    City Line Foods Recalls Pretzel Dogs for Undeclared Soy Allergen

    City Line Foods is recalling frozen pretzel dog products because they contain undeclared soy lecithin, a known allergen.

    Product
    Pennsylvania Firm Recalls Pretzel Dog Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E076000·2014-11-14

    Ford and Chrysler Recall Vehicles with Defective Bosch Air Bag Modules

    Ford and Chrysler are recalling vehicles with specific Bosch air bag modules where improper coating may prevent air bags and seat belt pretensioners from deploying in a crash.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·078-2014·2014-11-14

    Kasia's Deli Recalls Pierogi Products Due to Undeclared Allergens

    Kasia's Deli Inc. is recalling approximately 2,059 pounds of pierogi products because they contain undeclared wheat, soy, eggs, and milk.

    Product
    Kasia's Deli, Inc. — Illinois Firm Recalls Pierogi Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14E074000·2014-11-14

    FLY Racing Recalls Certain Model .357 Motorcycle Helmets

    FLY Racing is recalling specific Model .357 helmets because the retention strap ring may separate in high heat, increasing crash injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V732000·2014-11-13

    Toyota Recalls 2011 Camry Vehicles for Front Suspension Defect

    Toyota is recalling certain 2011 Camry vehicles because a damaged rubber boot on the front suspension lower arm ball joint may leak lubricant, causing premature wear and loosening.

    Product
    TOYOTA — TOYOTA CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V731000·2014-11-13

    Peterbilt Recalls 2015 389 Trucks Due to Steering Wheel Nut Issue

    PACCAR is recalling specific 2015 Peterbilt 389 trucks because the steering wheel attachment nut may be incorrect or improperly torqued, posing a crash risk.

    Product
    PETERBILT — PETERBILT 389
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E073000·2014-11-13

    Takata Frontal Air Bag Inflators Recalled for Rupture Risk

    Takata is recalling certain passenger frontal air bag inflators that may rupture during deployment, potentially causing serious injury or death.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15026·2014-11-13

    Daesung Tankless Gas Water Heaters Recalled for Fire Hazard

    Daesung Celtic Enersys is recalling Coaire and Quietside tankless gas water heaters because they can overheat and cause fires or property damage.

    Product
    Tankless gas water heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15025·2014-11-13

    Venmar Air Exchangers Recalled Due to Fire Hazard from Overheating Motors

    Venmar Ventilation is expanding a recall of air exchangers because the motors can overheat and cause fires. Consumers should stop using the units and contact the manufacturer for a free repair.

    Product
    Air exchangers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15024·2014-11-13

    Ventamatic Recalls Cool Draft Misting Fans Due to Fire and Shock Risk

    Ventamatic is recalling about 450 Cool Draft misting fans because improper wiring creates fire and electric shock hazards. Consumers should stop using the fans immediately.

    Product
    Cool Draft Misting Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V729000·2014-11-13

    Starcraft Bus Recalls Transit Buses Due to Wheelchair Lift Defect

    Forest River is recalling 2006-2012 Starcraft transit buses because wheelchair lift platform side plates may crack, posing an injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS STARQUEST, ULTRASTAR, ALLSTAR, XLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V730000·2014-11-13

    Starcraft Bus Recalls School Buses with Cracking Wheelchair Lifts

    Forest River is recalling 2010-2012 Starcraft Bus Quest and Prodigy school buses because wheelchair lift platform side plates may crack, posing an injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS QUEST, PRODIGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E065000·2014-11-13

    Carefree Latitude Awning Recall Due to Cracking Mounting Brackets

    Carefree is recalling Latitude awnings because mounting brackets may crack, causing the awning to fall and potentially injure people underneath.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0100-2015·2014-11-12

    Dancing Star LLC Recalls Date Flax Energy Bites for Salmonella Risk

    Dancing Star LLC is recalling specific lots of Date Flax with Turmeric energy bites because they may be contaminated with Salmonella.

    Product
    Date Flax with Turmeric Chunks of Energy (10# UPC 7-69270-20004-5); also Date Flax Turmeric Chunks of Energy and Rave Bites Date Flax with Turmeric (7 oz UPC 7-69270-70006-4).
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0095-2015·2014-11-12

    Grandma's Potato and Bacon Perogies Recalled for Undeclared Soy

    Buffalo SAV, Inc. is recalling Grandma's Potato & Bacon Perogies due to undeclared soy. The product was distributed in six states.

    Product
    GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink label and contains 14 - 2 lb bags per case. Manufactured by S&A Grandma's Food Inc. 196-44 Fasken Drive Toronto, ON M9W 5M8 (416) 679-8444, ww
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0101-2015·2014-11-12

    Dancing Star LLC Recalls Bulk Organic Carob Powder for Salmonella Risk

    Dancing Star LLC is recalling bulk organic carob powder due to potential Salmonella contamination. The product was distributed nationwide to retail stores.

    Product
    Bulk organic Carob powder (10# UPC 7-69270-80001-6)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2015·2014-11-12

    FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable glutathione vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0214-2015·2014-11-12

    FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0213-2015·2014-11-12

    FDA Recalls Papaverine Injection Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin injections due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0222-2015·2014-11-12

    Sodium Chloride Inhalation Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Sodium Chloride Inhalation 7% solution due to quality control issues affecting sterility assurance.

    Product
    SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0211-2015·2014-11-12

    FDA Recalls Papaverine HCL Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·14V727000·2014-11-12

    Hino Recalls 2012-2015 XFC Vehicles Due to Hybrid Motor Shaft Defect

    Hino is recalling 2012-2015 XFC vehicles because the hybrid motor output shaft may break, potentially causing the vehicle to stop moving and increasing crash risk.

    Product
    HINO — HINO XFC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2015·2014-11-12

    Recall of Chorionic Gonadotropin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 145 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.

    Product
    CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0223-2015·2014-11-12

    FDA Recalls Compounded Testosterone Cypionate Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance.

    Product
    TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0192-2015·2014-11-12

    Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns

    Creative Compounds is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0174-2015·2014-11-12

    FDA Recalls Alprostadil/Lidocaine Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Alprostadil/Lidocaine HCL vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0202-2015·2014-11-12

    Recall of Injectable Methylcobalamin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Methylcobalamin due to quality control issues affecting sterility assurance.

    Product
    METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0186-2015·2014-11-12

    FDA Recalls Dexpantenol Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Dexpantenol injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0210-2015·2014-11-12

    FDA Recalls Compounded Injectable Drug Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of a compounded injectable drug due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0203-2015·2014-11-12

    FDA Recalls Methycobalamin Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of Methycobalamin injectable due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0195-2015·2014-11-12

    FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable glutathione vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

    Product
    GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0212-2015·2014-11-12

    FDA Recalls Sterile Injectable Drug Due to Quality Control Concerns

    Oregon Compounding Centers is recalling sterile injectable drug vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0204-2015·2014-11-12

    Recall of Injectable Methycobalamin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of injectable Methycobalamin due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0156-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2015·2014-11-12

    FDA Recalls Bevacizumab/Dexamethasone Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Bevacizumab/Dexamethasone injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0219-2015·2014-11-12

    FDA Recalls Prednisolone Sodium Phosphate Eye Drops for Sterility Concerns

    Oregon Compounding Centers is recalling Prednisolone Sodium Phosphate ophthalmic drops due to quality control issues affecting sterility assurance.

    Product
    PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0176-2015·2014-11-12

    FDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns

    Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

    Product
    ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0189-2015·2014-11-12

    FDA Recalls Estradiol Cypionate Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Estradiol Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0227-2015·2014-11-12

    Vancomycin Injectable Syringes Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Vancomycin injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0201-2015·2014-11-12

    FDA Recalls Lidoaine HCL Solution Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Lidoaine HCL solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0197-2015·2014-11-12

    Hyaluronidase Injectable Recalled Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling hyaluronidase injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0225-2015·2014-11-12

    Tobramycin Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Tobramycin solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0187-2015·2014-11-12

    FDA Recalls DMPS Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling DMPS injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0182-2015·2014-11-12

    FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.

    Product
    CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0188-2015·2014-11-12

    FDA Recalls Epinephrine Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Epinephrine 1:1000 injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0220-2015·2014-11-12

    Procaine HCL Injectable Recall Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Procaine HCL injectable vials due to quality control issues affecting sterility assurance.

    Product
    PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0224-2015·2014-11-12

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0216-2015·2014-11-12

    FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0207-2015·2014-11-12

    Mitomycin Injectable Vials Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0215-2015·2014-11-12

    FDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling specific lots of a sterile injectable drug due to quality control issues that may compromise sterility.

    Product
    PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0177-2015·2014-11-12

    FDA Recalls AVASTIN Syringes Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling AVASTIN syringes because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

    Product
    AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0183-2015·2014-11-12

    Renacidin Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Renacidin solution due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0185-2015·2014-11-12

    FDA Recalls Dexamethasone Injectable Vials Due to Sterility Concerns

    Oregon Compounding Centers is recalling Dexamethasone injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0226-2015·2014-11-12

    FDA Recalls Trience Injectable Syringes Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Trience 8mg/2.0mL injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0206-2015·2014-11-12

    Mitomycin Injectable Vials Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0209-2015·2014-11-12

    FDA Recalls Injectable Papaverine HCL/Phentolamine/Prostaglandin Due to Sterility Concerns

    Oregon Compounding Centers is recalling specific lots of injectable Papaverine HCL/Phentolamine/Prostaglandin due to quality control issues affecting sterility assurance.

    Product
    PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0175-2015·2014-11-12

    Recall of Injectable Ascorbic Acid Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Ascorbic Acid (Vitamin B) due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0200-2015·2014-11-12

    Hydroxyprogesterone Caproate Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Hydroxyprogesterone Caproate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0184-2015·2014-11-12

    FDA Recalls Copper Sulfate Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Copper Sulfate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0228-2015·2014-11-12

    FDA Recalls Vitamin B Complex Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling Vitamin B Complex injectable vials due to quality control issues affecting sterility assurance.

    Product
    VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0099-2015·2014-11-12

    Dancing Star Recalls Carob Supergreens Chunks of Energy Due to Salmonella Risk

    Dancing Star LLC is recalling specific lots of Carob Supergreens Chunks of Energy and Rave Bites Carob Supergreens because they may be contaminated with Salmonella.

    Product
    Carob Supergreens Chunks of Energy (10# UPC 7-69270-10009-7); also, Carob Supergreens Chunks of Energy and Rave BItes Brand Carob Supergreens (7 oz UPC 7-69270-70008-8).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0199-2015·2014-11-12

    FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Hydroxocobalamin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0180-2015·2014-11-12

    Creative Compounds Recalls Ceftazidime Syringes Due to Sterility Concerns

    Oregon Compounding Centers is recalling Ceftazidime syringes because quality control issues observed during an FDA inspection may compromise sterility assurance.

    Product
    CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0218-2015·2014-11-12

    FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0194-2015·2014-11-12

    FDA Recalls Sterile Glutaraldehyde Solution Due to Quality Control Concerns

    Oregon Compounding Centers is recalling sterile glutaraldehyde solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0205-2015·2014-11-12

    FDA Recalls Injectable Methycobalamin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Methycobalamin vials due to quality control issues that present a potential risk to sterility assurance.

    Product
    METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0191-2015·2014-11-12

    Ganciclovir Syringes Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Ganciclovir syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0463-2015·2014-11-12

    Giorgio Foods Recalls Wheat Cheese Calzones Due to Metal Contamination

    Giorgio Foods Inc. is recalling bulk-packed Wheat Cheese Calzones due to potential metal contamination. The product was manufactured for the National School Lunch Program.

    Product
    Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed by: Giorgio Foods, Inc., PO Box 96, Temple, PA 19560 Manufactured 3/27/2014 Best by 3/27/2015 Product 8512 Lot 14086
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0168-2015·2014-11-12

    IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors

    Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.

    Product
    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0460-2015·2014-11-12

    K-Fat Inc. Recalls Sweetened Ginger Candy for Undeclared Sulfites

    K-Fat Inc. is recalling KFI Sweetened Ginger Candy because it contains undeclared sulfites. The product was distributed in New York and New Jersey.

    Product
    KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC. 13 MEADOW STREET, BROOKLYN, NY 11206, USA TEL: 718-381-0306 FAX: 718-381-0089 --- The product is packed in a clear, hard plastic container.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0173-2015·2014-11-12

    Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Alprostadil injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0198-2015·2014-11-12

    FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Hydroxocobalamin (B12) injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0208-2015·2014-11-12

    FDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Omnipaque injectable vials due to quality control issues affecting sterility assurance.

    Product
    OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0179-2015·2014-11-12

    FDA Recalls Calcium Chloride Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of Calcium Chloride Injectable due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0193-2015·2014-11-12

    Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0221-2015·2014-11-12

    FDA Recalls Pyridoxine HCL Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Pyridoxine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·14V726000·2014-11-12

    Wabash National Van Trailers Recalled for Brake Actuator Defect

    Wabash National is recalling 2014-2016 Van Trailers because defective brake actuators may cause dragging or overheating, increasing the risk of fire and crash.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0190-2015·2014-11-12

    FDA Recalls Ganciclovir Syringes Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 40 syringes of Ganciclovir due to quality control issues affecting sterility assurance found during an FDA inspection.

    Product
    GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0217-2015·2014-11-12

    FDA Recalls Compounded Injectable Drug Due to Sterility Concerns

    Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0158-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect

    Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.

    Product
    Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Hand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2015·2014-11-12

    Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction

    Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.

    Product
    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect

    Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2015·2014-11-12

    C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets

    C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.

    Product
    Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, s
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0462-2015·2014-11-12

    Saba Shark Cartilage Complex Recalled for Potential Salmonella Presence

    AMS Health Sciences is recalling Saba Shark Cartilage Complex dietary supplements due to the potential presence of Salmonella.

    Product
    Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2015·2014-11-12

    Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect

    Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.

    Product
    Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardiopleg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0457-2015·2014-11-12

    Buddy's Kitchen Recalls Fiesta Breakfast Scramble Due to Listeria

    Buddy's Kitchen, Inc. is recalling Fiesta Breakfast Scramble because an ingredient tested positive for Listeria monocytogenes.

    Product
    Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0456-2015·2014-11-12

    High Quality Organics Recalls Organic Ginger Tea Due to Salmonella

    High Quality Organics is recalling 780 lbs of Organic Ginger Tea Bag Cut after a sample tested positive for Salmonella.

    Product
    Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0169-2015·2014-11-12

    Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk

    Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.

    Product
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
    Category
    Medical Device
    Distribution
    Distributed nationwide

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