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.

301–400 of 516

  • ModerateFDA (Food)·F-1255-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 32,900 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; A96289 BREADER X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1130-2019·2019-04-17

    Lohxa Recalls Bismuth Subsalicylate Suspension Due to Incorrect Expiration Date

    Lohxa LLC is recalling Bismuth Subsalicylate Oral Suspension because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.

    Product
    Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1131-2019·2019-04-17

    Lohxa Recalls Phenobarbital Oral Solution Due to Incorrect Expiration Date

    Lohxa LLC is recalling Phenobarbital Oral Solution because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.

    Product
    Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1090-2019·2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - 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 (Drugs)·D-1113-2019·2019-04-17

    Gavilyte-N Recalled for Incorrect Flavor Labeling on Orange and Cherry Packets

    Lupin Somerset is recalling Gavilyte-N because orange and cherry flavor packets incorrectly list 'natural lemon flavor' as an ingredient.

    Product
    GAVILYTE-N — GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2019·2019-04-17

    ACUVUE OASYS for Astigmatism Contact Lenses Recalled for Packaging Seal Defects

    Johnson & Johnson Vision Care is recalling one lot of ACUVUE OASYS for Astigmatism contact lenses due to potential incomplete packaging seals.

    Product
    ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1243-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 20,000 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; A28986 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Food)·F-1244-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 2,400 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; A29322 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1119-2019·2019-04-17

    Arrow Two-Lumen Central Venous Catheter Set Recalled for Labeling Error

    Arrow International Inc is recalling 45 units of Two-Lumen Central Venous Catheterization Sets due to incorrect priming volume labeling on the lidstock.

    Product
    Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1275-2019·2019-04-17

    Walgreens Probiotic Recalled for Incorrect Bacterial Strain

    Merical, LLC is recalling Walgreens Probiotic 12.5 Billion Active Cultures because the product contains a different bacterial strain than listed on the label.

    Product
    Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsules; Dietary Supplement. Probiotic Blend 12.5 Billion CFU's L. rhamnosus HN001, L acidophilus La-14, L reuteri L.RE02. Other ingredients: Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate (vegetable sour
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1084-2019·2019-04-17

    X-Gen Recalls Clonidine Injection Vials Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCL Injection vials because the side carton incorrectly lists the concentration as 500 mcg instead of 100 mcg per mL.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2019·2019-04-17

    Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over

    Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2019·2019-04-17

    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 CM42500E-07
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1091-2019·2019-04-17

    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, 12mm Catalog Number: 040012 - 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 (Devices)·Z-1130-2019·2019-04-17

    Philips Recalls Two Azurion FlexArm Units Due to Cable Damage

    Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.

    Product
    Azurion FlexArm, 722079
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1118-2019·2019-04-17

    Arrow Two-Lumen Central Venous Catheterization Kit Recalled for Labeling Error

    Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.

    Product
    Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1126-2019·2019-04-17

    Ulrich Torque Limiting Handles Recalled for Exceeding Calibration Life

    Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles because they are beyond their 3-year calibration life.

    Product
    ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-1262-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 20,150 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; #22419 BATTER MX X2; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1103-2019·2019-04-17

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

    Professional Compounding Pharmacy is recalling compounded Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during a recent FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1105-2019·2019-04-17

    Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values

    Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1082-2019·2019-04-17

    Auro Pharmacies Recalls Biotin Injection Vials for pH Failure

    Auro Pharmacies Inc. is recalling 167 vials of Biotin 10 mg/mL Injection because the product failed to meet its pH label claim.

    Product
    Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1134-2019·2019-04-17

    GE Healthcare Recalls Thallous Chloride TI 201 Injection Due to Chemical Contamination

    Medi-Physics Inc. dba GE Healthcare is recalling Thallous Chloride TI 201 Injection vials because trace amounts of an impurity were detected in the manufacturing reagent.

    Product
    Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1121-2019·2019-04-17

    Lupin Recalls Telmisartan and Amlodipine Tablets Due to Stability Failures

    Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.

    Product
    TELMISARTAN AND AMLODIPINE — TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1106-2019·2019-04-17

    Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value

    Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1122-2019·2019-04-17

    AvKARE Recalls Telmisartan and Amlodipine Tablets Due to Impurities

    AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.

    Product
    Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-1107-2019·2019-04-17

    Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value

    Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.

    Product
    Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·19V306000·2019-04-16

    2019 Fleetwood and Holiday Rambler Motorhomes Recalled for Exhaust Defect

    REV is recalling 2019 Fleetwood Flair and Holiday Rambler Admiral motorhomes because the generator exhaust pipe placement may allow carbon monoxide to enter the vehicle.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, ADMIRAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E029000·2019-04-15

    Triumph Recalls Thruxton Motorcycles Due to Wiring Clearance Issue

    Triumph is recalling 2016-2018 Thruxton motorcycles because accessory fairing kits may damage wiring, causing loss of lights or engine stalls.

    Product
    TRIUMPH — TRIUMPH THRUXTON 1200R, THRUXTON 1200, THRUXTON A2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·19105·2019-04-12

    Fisher-Price Recalls Rock 'n Play Sleepers Due to Infant Death Reports

    Fisher-Price is recalling all Rock 'n Play Sleepers because over 30 infant fatalities have occurred. Consumers should stop using the product immediately and contact the company for a refund.

    Product
    All Models of Rock 'n Play Sleeper
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E028000·2019-04-12

    Cush Corp Recalls Trailer Axles Due to Wheel Separation Risk

    Cush Corp is recalling specific trailer suspension systems because a locking device may not be installed properly, allowing the wheel end to separate from the axle.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V299000·2019-04-12

    Honda Recalls 2018-2019 Odyssey for Transmission Control Unit Reboot Risk

    Honda is recalling 2018-2019 Odyssey vehicles because loose battery connections may cause the transmission to shift to Park, potentially damaging the parking rod and increasing crash risk.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V298000·2019-04-12

    Honda and Acura Recall Vehicles Due to Timing Belt Defect

    Honda is recalling specific 2018-2019 Acura and Honda vehicles because timing belt teeth may separate, potentially causing an engine stall and increasing crash risk.

    Product
    HONDA — HONDA, ACURA PILOT, TLX, ODYSSEY, RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·046-2019·2019-04-12

    Denver Processing Recalls Raw Pork and Beef Produced Without Inspection

    Denver Processing LLC is recalling raw pork and beef products produced without federal inspection. The products were distributed to retail locations in five states.

    Product
    JBS USA — Denver Processing LLC Recalls Raw Pork and Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·19V297000·2019-04-11

    Subaru Recalls Vehicles Due to Ignition Switch Spring Failure Risk

    Subaru is recalling specific 2005-2014 models because a broken spring in the ignition switch could cause the engine to turn off unexpectedly, increasing crash risk.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK, IMPREZA, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V293000·2019-04-11

    Chrysler Recalls 2013-2016 Dodge Dart Vehicles for Shifter Cable Defect

    Chrysler is recalling 2013-2016 Dodge Dart vehicles with 6-speed automatic transmissions because the shifter cable bushing may fail, allowing the cable to detach and increasing crash risk.

    Product
    DODGE — DODGE DART
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V296000·2019-04-11

    Karma Revero Recall: Side Air Bags May Not Deploy in Rollover

    Karma Automotive is recalling 2018 Revero vehicles because side curtain air bags may not deploy in a rollover crash due to a disabled sensor system.

    Product
    KARMA — KARMA REVERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19103·2019-04-11

    DICK'S Recalls Field & Stream Tree Stands Due to Fall Hazard

    DICK'S Sporting Goods is recalling Field & Stream Timberline Hang On tree stands because the seat weld can break, posing a fall hazard.

    Product
    Field & Stream Timberline Hang On tree stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19104·2019-04-11

    Specialized Recalls Bicycles with Steerer Tube Collars Due to Fall Hazards

    Specialized is recalling about 63,000 bicycles because the steerer tube collar can crack, causing sudden loss of steering control and posing fall and injury hazards.

    Product
    Specialized Roubaix, Ruby, Diverge, and Sirrus Bicycles with steerer tube collars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1211-2019·2019-04-10

    FDA Recalls Chilean Salmon for Listeria monocytogenes Contamination

    Procesadora Aguas Claras LTDA. is recalling Premium Sustainable Atlantic Salmon from Chile due to a positive test for Listeria monocytogenes. The product was distributed to institutional customers in seven states.

    Product
    Premium Sustainable Atlantic Salmon (Farm Raised); 22 lb. case - Master carton - corrugated cardboard box. Internal Packaging: IQF vacuum packed with tray. Origin: Chili Packed for Osamu Corporation, Carson, CA For institutional use only
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0977-2019·2019-04-10

    O-Two Medical e600 Ventilator Recalled for Fire Risk

    O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.

    Product
    e600 Automatic Transport Ventilator, Model Number 01EVE600
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Food)·F-1233-2019·2019-04-10

    Allen's Wild Blueberries Recalled for E. coli O157:H7 Contamination

    Allen's Blueberry Freezer, Inc. is recalling 37,800 pounds of Wild Sweet Allen's Wild Blueberries because the product tested positive for E. coli O157:H7.

    Product
    Wild Sweet ALLEN'S BLUEBERRIES WILD BLUEBERRIES IQF 30 LBS. NET 13.6 Kg. Packaged in a corrugated carton. Keep frozen at zero degrees F or below.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1073-2019·2019-04-10

    Pfizer Recalls Sodium Bicarbonate Injection Vials Due to Glass Particulates

    Pfizer is recalling 8.4% Sodium Bicarbonate Injection vials because they contain glass particulates. The recall covers 283,400 vials distributed in the United States and Puerto Rico.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0976-2019·2019-04-10

    O-Two Medical e500 Ventilator Recalled for Fire Hazard

    O-Two Medical is recalling 136 e500 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.

    Product
    e500 Automatic Transport Ventilator, Model Number 01EVE500
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0978-2019·2019-04-10

    O-Two Medical e700 Ventilator Recalled for Fire Risk

    O-Two Medical Technologies is recalling 632 e700 Automatic Transport Ventilators because a manufacturing defect could cause the unit to catch fire.

    Product
    e700 Automatic Transport Ventilator, Model Number 01EVE700
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-1075-2019·2019-04-10

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, because an impurity was detected. The recall covers 179,544 bottles distributed in Arizona, Indiana, and Tennessee.

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 630
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·19V290000·2019-04-10

    Mercedes-Benz Metris Recalled for Corroding Power Steering Bolts

    Daimler Vans USA is recalling 2016-2017 Metris vans in 24 states and DC because aluminum power steering bolts may corrode and fracture, causing loss of steering assist.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V291000·2019-04-10

    BMW Recalls 2019 X3 and X4 Models Due to Air Bag Defect

    BMW is recalling 2019 X3 and X4 vehicles because the instrument panel may be improperly manufactured, potentially preventing the passenger air bag from deploying.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1228-2019·2019-04-10

    Willamette Valley Frozen Red Raspberries Recalled for Hepatitis A Risk

    Willamette Valley Pie Company is recalling frozen red raspberries due to potential contamination with Hepatitis A virus. The product was distributed in California, Oregon, Texas, and Washington.

    Product
    Frozen IQF Red Raspberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is 0 22518 87750 9. The label of 2 lb. bag is read in parts: "***Red Raspberries ***WILLAMETTE VALLEY FRUIT ***Ingredients: Red Raspberries*** 2994 82nd Avenue NE Salem,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1229-2019·2019-04-10

    Willamette Valley Frozen Strawberries Recalled for Hepatitis A Risk

    Willamette Valley Pie Company is recalling 1,448 cases of frozen strawberries due to potential Hepatitis A virus contamination. The product was distributed in California, Oregon, Texas, and Washington.

    Product
    Frozen IQF Strawberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is UPC: 0 22518 87710 3. The label of 2 lb. bag is read in parts: "***STRAWBERRIES***KEEP FROZEN***Net Weight 2 lbs. ***WILLAMETTE VALLEY FRUIT ***". The white adhesiv
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1087-2019·2019-04-10

    Zimmer Biomet Recalls RingLoc Hip System Self-Tapping Bone Screws

    Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.

    Product
    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2019·2019-04-10

    Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error

    Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.

    Product
    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1232-2019·2019-04-10

    Century Snacks Recalls Honey Bliss Nut Mix for Undeclared Milk Allergen

    Century Snacks LLC is recalling Snak Club Honey Bliss Nut Mix because the Honey Butter Seasoning contains milk, a major allergen, that was not declared on the packaging.

    Product
    Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almonds, Peanuts, Pumpkin Seeds, Pistachios, Pecans & Honey Sesame Sticks. NET WET,3-oz. and 5.75-oz plastic pouches and 25 lb. bulk bags 3 oz. UPC: 0 87076 21152 3, 5.75 oz. UPC: 0 87076 51152 4
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-1231-2019·2019-04-10

    Fungi Perfecti Recalls Host Defense Blood Sugar Supplement for Undeclared Wheat

    Fungi Perfecti LLC is recalling Host Defense MycoBotanicals Blood Sugar dietary supplements because they contain undeclared wheat. The recall affects 11,042 bottles distributed in the US, Canada, and Norway.

    Product
    Host Defense MycoBotanicals Blood Sugar, dietary supplement, 500mg capsules, 60 ct per bottle, serving size 2 capsules per day. UPC: 6 33422 70474 6 (distributed in US) UPC: 8 22078 71303 9 (distributed in Canada) The product is labeled in parts: "***HOST DEFENSE MYCO BOTA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1235-2019·2019-04-10

    Better Made Potato Chips Recalled for Undeclared Milk

    Better Made Snack Foods is recalling 660 bags of Original Potato Chips due to undeclared milk. The product was sold in Michigan, Ohio, and via mail order nationwide.

    Product
    Better Made Snack Foods Family Size $3.99 Original Potato Chips 10oz. flexible pouch bag UPC code of 041633063048 12 bags per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V287000·2019-04-10

    2019 Jeep Renegade and Fiat 500X Recalled for Software Defect

    Chrysler is recalling 2019 Jeep Renegade and Fiat 500X vehicles because incorrect software may disable passive safety features, increasing injury risk in a crash.

    Product
    JEEP — JEEP, FIAT RENEGADE, 500X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V286000·2019-04-10

    Spartan Recalls 2012-2018 Utilimaster Reach Vehicles for Wiper Defect

    Spartan Motors is recalling 2012-2018 Utilimaster Reach vehicles because improper electrical grounding may cause windshield wipers to stop working, reducing visibility.

    Product
    UTILIMASTER — UTILIMASTER REACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V285000·2019-04-10

    North Central Emergency Recalls Ambulances Due to Brake Light Wiring Defect

    North Central Emergency is recalling 2016-2018 ambulances because brake lights may illuminate without the pedal being pressed, potentially confusing other drivers.

    Product
    NORTH CENTRAL EMERGENCY — NORTH CENTRAL EMERGENCY, CHEVROLET FORD E-350, FORD E-450, G4500, CHEVY G4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2019·2019-04-10

    Biomet Cement Plug Inserter Recalled for Sterilization Validation Issues

    Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.

    Product
    Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1077-2019·2019-04-10

    Morphine Sulfate API Recalled for Microbial Contamination Out of Specification

    Johnson Matthey Inc. is recalling Morphine Sulfate USP Milled API due to bioburden out of specification results.

    Product
    Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1234-2019·2019-04-10

    Newport Ingredients Recalls Maika'i Sweet Honey Nut Snack Mix for Undeclared Milk

    Newport Ingredients is recalling Maika'i Sweet Honey Nut Snack Mix due to undeclared milk. The product was distributed in Hawaii.

    Product
    Maika'i Sweet Honey Nut Snack Mix, Honey Sesame Sticks, Almonds, Pumpkin Seeds, Peanuts, Pistachios & Pecans. NET WT. 8 oz. (226) clear plastic bags; UPC: 6 18551 60132 6 Packed on shared equipment with peanuts, tree nuts, wheat, soy and milk. Distributed by Foodlan
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1077-2019·2019-04-10

    Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

    Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.

    Product
    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1078-2019·2019-04-10

    Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error

    Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.

    Product
    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A6
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Drugs)·D-1069-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high levels of impurities were found at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1078-2019·2019-04-10

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1072-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

    Product
    Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1085-2019·2019-04-10

    Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error

    Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1084-2019·2019-04-10

    Advanced Bionics Recalls Three Naída CI Q70 Sound Processors

    Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1076-2019·2019-04-10

    Pacific Compounding Recalls Cefuroxime Injection Due to Particulate Matter

    Pacific Compounding Pharmacy is recalling one lot of Cefuroxime injection because FDA analysis found rubber stopper fragments in the product.

    Product
    Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1079-2019·2019-04-10

    KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1074-2019·2019-04-10

    Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration

    Jubilant Cadista Pharmaceuticals is recalling 12,960 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on the tablet edges.

    Product
    Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1230-2019·2019-04-10

    Snow's Mint Chip Ice Cream Recalled for Undeclared Yellow #5 Dye

    Snow's Acquisition, LLC is recalling Mint Chip Ice Cream with Dark Chocolate Chunks because the product contains undeclared Yellow #5 dye.

    Product
    Snow's PREMIUM ICE CREAM Mint Chip Mint Ice Cream with Dark Chocolate Chunks 1.5 QUART (1.42L) KEEP FROZEN, UPCE: 0 48896400139
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1074-2019·2019-04-10

    Abbott Recalls CELL-DYN Emerald Analyzers Due to Quality Control Errors

    Abbott Laboratories is recalling 6,353 CELL-DYN Emerald analyzers worldwide because they may generate incorrect low quality control results for red blood cells and platelets.

    Product
    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·045-2019·2019-04-10

    Yoakum Packing Recalls Venison Sausage Due to Pork Mislabeling

    Yoakum Packing Co. is recalling smoked venison sausage that contains pork not listed on the label. The recall affects products sold in Texas.

    Product
    Yoakum Packing Co. — Yoakum Packing Co. Recalls Venison Sausage Products Due to Mislabeling
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1071-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1070-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2019·2019-04-10

    Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

    Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1079-2019·2019-04-10

    Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors

    Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.

    Product
    iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1075-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1080-2019·2019-04-10

    McKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues

    Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.

    Product
    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
    Category
    Medical Device
    Distribution
    27 states
  • LowFDA (Drugs)·D-1067-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide

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