The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
256
High
403
Moderate
156
Low
23

Of the 896 recalls this month scored against our rubric, 6% are Critical, 29% are Severe.

301–400 of 896

  • ModerateFDA (Food)·F-1488-2016·2016-06-22

    Oasis Foods Canola Fry Shortening Recalled for Foreign Material

    Oasis Foods is recalling Canola Fry Shortening because 35 lb bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1956-2016·2016-06-22

    Beckman Coulter Access 2 Immunoassay System Recall for Thermal Component Defects

    Beckman Coulter is recalling four Access 2 Immunoassay Systems because missing thermal components may cause internal temperature excursions, delaying patient result reporting.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1035-2016·2016-06-22

    Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities

    Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.

    Product
    Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2016·2016-06-22

    Miami Fat Supply Recalls Red Head 2 Fat Harvesting Canisters

    Miami Fat Supply is recalling 443 Red Head 2 Reusable Fat Harvesting Canisters because they were marketed without FDA clearance and are not approved for multiple use.

    Product
    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1980-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1981-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters

    Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2016·2016-06-22

    Integra Recalls TS Series Depth Gauges for Incorrect Markings

    Integra LifeSciences is recalling 71 TS Series Depth Gauges because some units exceed length specifications or have incorrect millimeter markings.

    Product
    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2001-2016·2016-06-22

    Natus neoBLUE Phototherapy System Recall for Warning Label Update

    Natus Medical is recalling 13,541 neoBLUE Phototherapy systems to add a warning statement to the instructions and provide a laminated Quick Guide for each device.

    Product
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1499-2016·2016-06-22

    Chef's Quality Clear Liquid Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Clear Liquid Shortening because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Clear Liquid Shortening, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00481 2
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1508-2016·2016-06-22

    Silver Source Soy Salad Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling 1,200 containers of Silver Source Soy Salad Oil due to reports of high density polyethylene resin trim rings in the bottles.

    Product
    Silver Source Soy Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022346
    Category
    Food
    Distribution
    13 states
  • LowFDA (Drugs)·D-1031-2016·2016-06-22

    Galderma Recalls Doxycycline Capsules Due to Missing Lot and Expiration Dates

    Galderma Laboratories is recalling Doxycycline USP Capsules 40 mg because some bottles are missing lot numbers or expiration dates.

    Product
    Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1949-2016·2016-06-22

    Synthes Recalls Six LCP Dia-Meta Volar Distal Radius Plates Due to Packaging Error

    Synthes (USA) Products LLC is recalling six LCP Dia-Meta Volar Distal Radius Plates because the preprinted outer boxes were incorrect, though the internal product labels are accurate.

    Product
    LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1034-2016·2016-06-22

    Valeant Recalls Librax Capsules Due to Failed Impurity Specifications

    Valeant Pharmaceuticals is recalling specific lots of Librax capsules because they failed impurity and degradation specifications.

    Product
    LIBRAX — LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1029-2016·2016-06-22

    Genzyme Recalls Hectorol Injection Vials Due to Incorrect Barcode Labeling

    Genzyme is recalling 2,350 vials of Hectorol (doxercalciferol) injection because the vial labels contain an incorrect barcode. The affected product was distributed to Michigan, Pennsylvania, and New Jersey.

    Product
    Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Devices)·Z-1948-2016·2016-06-22

    Leica Biosystems Recalls Ariol Automated Scanning Microscopes Due to Software Issue

    Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope systems because a manufacturing error resulted in an improperly activated Windows 7 operating system.

    Product
    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1036-2016·2016-06-22

    Sandoz Recalls Lisinopril Tablets Due to Missing Package Insert

    Sandoz Inc is recalling 3,048 bottles of Lisinopril Tablets USP, 30 mg, because the package insert is incorrect or missing.

    Product
    Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V450000·2016-06-21

    Forest River Recalls 2016-2017 Flagstaff and Work N' Play Trailers

    Forest River is recalling 2016-2017 Flagstaff and Work N' Play trailers because a propane regulator sight glass may crack, allowing gas to leak and potentially cause a fire.

    Product
    FOREST RIVER — FOREST RIVER FLAGSTAFF, WORK AND PLAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V452000·2016-06-21

    Navistar Recalls 2016 IC Bus RE School Buses for Seat Defect

    Navistar is recalling 2016 IC Bus RE school buses because child seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    IC BUS — IC BUS RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16199·2016-06-21

    Tommee Tippee Electric Bottle and Food Warmers Recalled for Fire Hazard

    Mayborn USA is recalling about 255,000 Tommee Tippee electric bottle and food warmers due to a fire hazard. The units can overheat, melt, smoke, and catch fire.

    Product
    Electric bottle and food warmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V449000·2016-06-21

    GM Recalls 2016 Chevrolet Equinox and GMC Terrain for Incorrect Tire Labels

    General Motors is recalling specific 2016 Chevrolet Equinox and GMC Terrain vehicles because their certification labels may display incorrect tire and rim size information.

    Product
    GMC — GMC, CHEVROLET TERRAIN, EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V451000·2016-06-21

    Gillig Recalls 2012-2016 Low Floor Vehicles Due to Flashing Brake Lights

    Gillig is recalling 112 model year 2012-2016 Low Floor vehicles because the rear brake lights may flash inadvertently, which could confuse other drivers and increase crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V453000·2016-06-21

    Navistar Recalls 2017 International Trucks Due to Engine Stall Risk

    Navistar is recalling 1,191 model year 2017 International trucks because an electrical short in the engine control module can cause the engine to stall without restarting.

    Product
    INTERNATIONAL — INTERNATIONAL LONESTAR, PROSTAR, PAYSTAR, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·052-2016·2016-06-20

    U.S. Cado Holdings Recalls Imported Swai Fillets for Regulatory Violations

    U.S. Cado Holdings is recalling approximately 25,760 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting FSIS residue testing requirements.

    Product
    U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting FSIS Requirements
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·16V447000·2016-06-20

    Eldorado Shuttle Buses Recalled for Electrical Component Fire Risk

    Eldorado is recalling 2016 Aerotech, Aero Elite, and Advantage shuttle buses because a component in the electrical power distribution center may break, causing electrical arcing and increasing the risk of fire.

    Product
    ELDORADO — ELDORADO ADVANTAGE, AEROTECH, AERO ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E058000·2016-06-20

    Speedtech Recalls Nitrous Solenoid Valves Due to Welding Defect

    Speedtech LLC is recalling Nitrous Solenoid Valves used in drag racing nitrous oxide systems because improper welding may cause the valve to separate and eject the piston under pressure.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·051-2016·2016-06-18

    GNP Company Recalls Chicken Products Due To Foreign Matter Contamination

    GNP Company is recalling approximately 55,608 pounds of chicken products that may be contaminated with sand and black soil. No illnesses have been reported.

    Product
    Pilgrim's Pride Corporation — GNP Company Recalls Chicken Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·050-2016·2016-06-17

    Red Bowl Wonton and Dumpling Products Recalled for Undeclared Egg Allergen

    Red Bowl Foods is recalling wonton and dumpling products because they contain egg, a known allergen, that is not declared on the label.

    Product
    Red Bowl Food Corporation — Red Bowl Food Corporation Recalls Wonton and Dumpling Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·16V446000·2016-06-17

    Indian Recalls 2014-2016 Motorcycles Due to Fire Risk

    Indian Motorcycle is recalling 2014-2016 models because engine misfires can raise exhaust temperatures, increasing the risk of fire.

    Product
    INDIAN — INDIAN CHIEF CLASSIC, CHIEFTAIN, ROADMASTER, VINTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V441000·2016-06-16

    Eldorado Amerivan 10 Recall for Fuel Line Leak Fire Risk

    Eldorado is recalling 2012-2016 Amerivan 10 vehicles because an improperly installed fuel line may leak and cause a fire.

    Product
    ELDORADO — ELDORADO AMERIVAN 10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V442000·2016-06-16

    Mercedes-Benz Recalls 2015-2016 Models for Seatbelt Anchor Bolt Defect

    Mercedes-Benz is recalling certain 2015-2016 models because the right rear seatbelt anchor bolt may be incorrectly installed, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450, AMG ML63, ML250, ML350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V443000·2016-06-16

    E-One Recalls Cyclone II and Typhoon Vehicles for Electrical Fire Risk

    E-One is recalling 2014-2016 Cyclone II and Typhoon vehicles because a power control module defect may cause a short circuit, leading to electrical damage or fire.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V444000·2016-06-16

    Land Rover Recalls 2016 LR4 Vehicles Due to Frontal Air Bag Defect

    Jaguar Land Rover is recalling 2016 LR4 vehicles because the driver-side frontal air bag may not inflate properly, increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER LR4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0966-2016·2016-06-15

    FDA Recalls Thin and Slim Thermogenic Fat Burner for Unapproved Ingredient

    Novacare, LLC is recalling The Store Thin and Slim Thermogenic Fat Burner because FDA sampling found salicylic acid, an ingredient not approved for dietary supplements.

    Product
    The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0964-2016·2016-06-15

    Novacare Recalls MetaPro 360 Supplement Containing Unapproved Salicylic Acid

    Novacare, LLC is recalling MetaPro 360 Metabolic Accelerator dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

    Product
    MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0970-2016·2016-06-15

    FDA Recalls Asia Black 25 Ephedra Extreme Fat Burner for Unapproved Ingredients

    Novacare, LLC is recalling Asia Black 25 Ephedra Extreme Fat Burner because FDA sampling confirmed the presence of salicylic acid, an unapproved ingredient in dietary supplements.

    Product
    Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0960-2016·2016-06-15

    Fuel Up High Octane capsules recalled for undeclared sildenafil analogue

    Reesna, Inc. is recalling Fuel Up High Octane capsules because they contain undeclared hydroxythiohomosildenafil, an analogue of the prescription drug Sildenafil.

    Product
    FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1428-2016·2016-06-15

    Rucker's Recalls Uncle Buck's Trail Mix Due to Listeria Risk

    Rucker's Wholesale & Service Co. is recalling Uncle Buck's Sweet & Salty trail mix because an ingredient may be contaminated with Listeria monocytogenes.

    Product
    labled in part "Uncle Buck's Sweet & Salty trail mix" packaged in a clear 3 oz plastic bag with attached green and orange label with yellow and black writing. item number: 7339, UPC # 752545073390.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0957-2016·2016-06-15

    Baxter Recalls Sodium Chloride Injection Due to Insect Particulate Matter

    Baxter Healthcare is recalling 255,852 bags of 0.9% Sodium Chloride Injection because customers reported finding an insect in the primary container.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0962-2016·2016-06-15

    FDA Recalls Thermo FX Supplement for Unapproved Salicylic Acid

    Novacare, LLC is recalling The People's Chemist Thermo FX Barely Legal Thermogenic Aid because FDA sampling confirmed the presence of salicylic acid in the product.

    Product
    The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0959-2016·2016-06-15

    Fuel Up Plus capsules recalled for undeclared sildenafil analogue

    Reesna, Inc. is recalling Fuel Up Plus capsules marketed as a dietary supplement because they contain undeclared hydroxythiohomosildenafil, an analogue of the ED drug sildenafil.

    Product
    FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1010-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #4 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1025-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #3 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.

    Product
    QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0965-2016·2016-06-15

    FDA Recalls Thin and Slim Burn Fat Now Supplement for Unapproved Ingredient

    Novacare, LLC is recalling Thin and Slim Burn Fat Now dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

    Product
    Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0988-2016·2016-06-15

    FDA Recalls 1-HCG 1000 IU/ML Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0958-2016·2016-06-15

    Baxter Recalls Dextrose Injection Due to Insect Contamination

    Baxter Healthcare is recalling Dextrose Injection, USP, 70% due to confirmed reports of an insect found in the primary container.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2016·2016-06-15

    FDA Recalls MaxOut Body Fat Burner for Unapproved Salicylic Acid

    Novacare, LLC is recalling MaxOut Body Fat Burner with Ephedra because FDA sampling confirmed the presence of salicylic acid in the dietary supplement.

    Product
    Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1006-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.

    Product
    QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V440000·2016-06-15

    Mercedes-Benz Recalls 2016 GLE450 Vehicles Due to Engine Shutdown Risk

    Mercedes-Benz is recalling 5,826 model year 2016 GLE450 vehicles because a software error may cause the engine to shut down while braking, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0984-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0983-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.

    Product
    ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1368-2016·2016-06-15

    Pulmuone Korean Noodles Recalled for Undeclared Milk Allergen

    Pulmuone Foods is recalling Korean Noodles in a Savory Black Bean Sauce because the product contains undeclared milk.

    Product
    Korean Noodles in a Savory Black Bean Sauce, 46.6oz, UPC 7-53214-73298-3, Food Item No. 1027557, Pack Size: 8.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1027-2016·2016-06-15

    FDA Recalls Itraconazole and Mupirocin Nasal Spray Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.

    Product
    ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0985-2016·2016-06-15

    Gentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.

    Product
    GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1026-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Otic Solution Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1000-2016·2016-06-15

    Methylcobalamin Injection Recalled Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.

    Product
    METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1426-2016·2016-06-15

    Lee Seed Company Recalls Yogurt Super Soynuts for Undeclared Milk

    Lee Seed Company is recalling Yogurt Super Soynuts because the product contains undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Yogurt Super Soynuts packaged in 16 oz. plastic bags and packaged in holiday tins. Lee Seed Company, Inc., Inwood, Iowa.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0968-2016·2016-06-15

    Dietary Supplement Recalled for Unapproved Salicylic Acid Content

    Novacare, LLC is recalling Thin and Slim Naturally AM dietary supplements because FDA sampling confirmed the presence of unapproved salicylic acid.

    Product
    Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0997-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Injectable Vitamin Mixture for Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product sterility.

    Product
    MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1018-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 3 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 3 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V437000·2016-06-15

    Thor Motor Coach Tuscany Recalled for Brake Signal Defect

    Thor Motor Coach is recalling 2014-2016 Tuscany motor homes because the brake signal to towed devices may not deactivate, causing dragging brakes and fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1425-2016·2016-06-15

    Mountain Thins Trail Mix Recalled for Listeria Contamination Risk

    Brown & Haley Inc. is recalling Mountain Thins Trail Mix flavor due to potential Listeria monocytogenes contamination.

    Product
    Mountain Thins Trail Mix flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1916-2016·2016-06-15

    Hill-Rom Recalls Liko Universal SlingBars Due to Center Bolt Failure Risk

    Hill-Rom is recalling Liko Universal SlingBars because the center bolt may weaken and break, posing a risk of patient falls and injury.

    Product
    Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1439-2016·2016-06-15

    Wylwood Frozen Broccoli Cuts Recalled for Potential Listeria Contamination

    Alimentos Congelados, S.A. is voluntarily recalling 1,800 cases of Wylwood Fresh Frozen Broccoli Cuts due to potential Listeria monocytogenes contamination.

    Product
    Wylwood Fresh Frozen Broccoli Cuts, NET WT. 16 OZ Code: A25335P and A15335P Dist By: Save-A-Lot Stores, Earth City, MO.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0971-2016·2016-06-15

    FDA Recalls Black Widow 25 Ephedra Fat Burner for Unapproved Ingredient

    Novacare, LLC is recalling Black Widow 25 Ephedra Super Potent Fat Burner because FDA sampling confirmed the presence of salicylic acid in the product.

    Product
    Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1024-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Vitamin B Complex Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Vitamin B Complex # 3 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1005-2016·2016-06-15

    Phosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of Phosphatidylcholine/Deoxycholic Acid due to FDA inspection findings regarding sterility assurance.

    Product
    PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1421-2016·2016-06-15

    Aldi Millville Protein Chew Bars Recalled for Listeria Risk

    Schulze & Burch Biscuit Co is recalling Aldi's Millville protein chew bars because a supplier reported a Listeria monocytogenes positive result for an ingredient.

    Product
    Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0972-2016·2016-06-15

    Methyldrene Original 25 Ephedra ECA Stack Recalled for Unapproved Salicylic Acid

    Novacare, LLC is recalling Methyldrene Original 25 Ephedra ECA Stack dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug.

    Product
    Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2016·2016-06-15

    FDA Recalls Compounded HCG and Vitamin Injections for Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded HCG, methylcobalamin, and folic acid injections due to FDA inspection findings regarding sterility assurance.

    Product
    HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0961-2016·2016-06-15

    FDA Recalls Fataway Ultimate Stack Supplement for Unapproved Salicylic Acid

    Novacare, LLC is recalling Thin and Slim Fataway Ultimate Stack with Chromium because FDA sampling found unapproved salicylic acid in the dietary supplement.

    Product
    Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0969-2016·2016-06-15

    Novacare Recalls Thin and Slim Extreme Stack Fat Burner Supplement

    Novacare, LLC is recalling Thin and Slim Extreme Stack Fat Burner dietary supplements because FDA sampling confirmed the presence of salicylic acid.

    Product
    Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0978-2016·2016-06-15

    FDA Recalls 17-0H Progesterone Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 17-0H Progesterone vials because FDA inspections found GMP violations that may affect sterility.

    Product
    17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1009-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #1 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1020-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 5 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 5 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1422-2016·2016-06-15

    Aldi Millville Protein Chew Bars Recalled for Listeria Risk

    Schulze & Burch Biscuit Co is recalling Aldi's Millville protein chew bars because a supplier reported a Listeria monocytogenes positive test for an ingredient.

    Product
    Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1013-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Testosterone Cypionate 150mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0973-2016·2016-06-15

    Novacare Recalls Unapproved Dietary Supplements Containing Salicylic Acid

    Novacare, LLC is recalling Xcellerator dietary supplements because FDA sampling confirmed the presence of salicylic acid in products marketed without an approved NDA/ANDA.

    Product
    Xcellerator (product not labeled)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1002-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin/Folic Acid Vials

    Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid vials due to GMP violations that may impact sterility.

    Product
    METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1016-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 1 vials because FDA inspections found violations that may affect product sterility.

    Product
    TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1007-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #2 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #2 vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1019-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of TRI-MIX # 4 in Nevada due to GMP violations that may impact sterility.

    Product
    TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1370-2016·2016-06-15

    Pulmuone Noodles Recalled for Undeclared Milk Allergen

    Pulmuone Foods is recalling Noodles with Fire-roasted Black Bean Sauce because the product contains undeclared milk.

    Product
    Noodles with Fire-roasted Black Bean Sauce, 23.3oz, UPC 7 53214 30021 2, Food Item No. 30021, Pack Size: 16.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1427-2016·2016-06-15

    Publix Cranberry Nut & Seed Mix Recalled for Listeria Risk

    Publix Super Markets is recalling Cranberry Nut & Seed Mix due to possible Listeria monocytogenes contamination. The product was distributed in six southeastern states.

    Product
    Publix Cranberry Nut & Seed Mix, 7.05 ounce plastic container. Manufactured by Publix Supermarkets in Lakeland, FL.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1438-2016·2016-06-15

    Frontier Co-op Hojicha Tea Recalled Due to Potential Salmonella Contamination

    Frontier Natural Products CO-OP is recalling specific lots of Hojicha Tea due to potential Salmonella contamination. Consumers should stop using the affected products.

    Product
    16 oz. foil packages of Frontier Co-op Hojicha Tea Certified Organic Camellia sinensus, Norway, IA 52318
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methyl B12 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect sterility.

    Product
    M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0982-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1922-2016·2016-06-15

    Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns

    Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.

    Product
    Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.