The Recall Desk

Archive

May 2019 recalls

587 recalls were announced in May 2019.

What the numbers show

Critical
22
Severe
152
High
209
Moderate
184
Low
20

Of the 587 recalls this month scored against our rubric, 4% are Critical, 26% are Severe.

401–500 of 587

  • SevereNHTSA·19V356000·2019-05-10

    Forest River Recalls 2019-2020 R-POD Travel Trailers Due to Fire Risk

    Forest River is recalling 2019-2020 R-POD travel trailers because a refrigerator wire may be connected to a breaker that allows too much current, increasing the risk of fire.

    Product
    FOREST RIVER — FOREST RIVER R-POD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V355000·2019-05-10

    Forest River Cherokee Travel Trailer Recall for Incorrect Federal Placard

    Forest River is recalling 2018-2019 Cherokee travel trailers because the Federal Placard may list incorrect axle and capacity information, potentially leading to vehicle overload.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V348000·2019-05-09

    Chrysler Recalls 2017-2019 Pacifica Vehicles Due to Battery Ground Defect

    Chrysler is recalling 2017-2019 Pacifica vehicles with stop/start systems because a loose battery ground connection may cause power steering loss or stalling, increasing crash risk.

    Product
    CHRYSLER — CHRYSLER PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V350000·2019-05-09

    Land Rover Recalls 2016-2017 Range Rovers for Seat Belt Defect

    Jaguar Land Rover is recalling 2016-2017 Range Rover and Range Rover Sport vehicles because the driver's seat belt may not lock properly during braking, increasing injury risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V347000·2019-05-09

    Chrysler Recalls Ram Pickup Trucks Due to Tailgate Latch Fracture Risk

    Chrysler is recalling specific Ram 1500, 2500, and 3500 pickup trucks because a tailgate latch component may fracture, causing the tailgate to open while driving and creating a road hazard.

    Product
    RAM — RAM 3500, 1500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V352000·2019-05-09

    BMW Recalls 2019-2020 Models for Improperly Folded Knee Air Bags

    BMW is recalling specific 2019-2020 models because knee air bag assemblies may be improperly folded and assembled. This defect could prevent the air bags from deploying as intended, increasing the risk of injury.

    Product
    BMW — BMW M2, 330I, 430I, 440I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19119·2019-05-09

    Havertys Recalls Beckley Entertainment Hutches Due to Falling Shelf Hazard

    Havertys is recalling Beckley Entertainment Hutches because the top shelf can fall, posing an injury hazard. The company has received 12 reports of the shelf falling, including two minor injuries.

    Product
    Beckley Entertainment Hutches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V353000·2019-05-09

    Stainless & Repair Recalls Whelen Brake Lights on Ford and Freightliner Trucks

    Stainless & Repair is recalling certain 1994-1995 Ford L9000 and 2016-2017 Freightliner M2-112 trucks equipped with Whelen brake lights that may illuminate without the brake pedal being pressed.

    Product
    FORD — FORD, FREIGHTLINER L9000, M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1323-2019·2019-05-08

    Hercules Candy Company Recalls Cashew Brittle Bits for Undeclared Peanuts

    Hercules Candy Company is recalling 15 bags of Cashew Brittle Bits because they may contain undeclared peanuts. Consumers should stop eating the product.

    Product
    Cashew Brittle Bits in clear 4oz bag with a Best By date of 07/14/19 and barcode number of 00369
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1263-2019·2019-05-08

    Losartan Potassium Tablets Recalled Due to Trace Nitrosamine Impurity

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets 50 mg due to trace amounts of the impurity NMBA found in the active ingredient.

    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 6
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1266-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 100 mg, because FDA labs confirmed the presence of the impurity NMBA above acceptable levels.

    Product
    Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2019·2019-05-08

    Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 19 vials of BPlex injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1261-2019·2019-05-08

    Customceutical Compounding Recalls Trimix HIGH Vials Due to Sterility Concerns

    Customceutical Compounding is recalling Trimix HIGH injectable vials because the company cannot ensure the product is sterile. The recall covers 3 vials distributed nationwide.

    Product
    Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1248-2019·2019-05-08

    Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

    Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1267-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

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

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1256-2019·2019-05-08

    Customceutical Compounding Recalls HCG Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 12 vials of compounded HCG injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1269-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

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

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

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

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2019·2019-05-08

    Customceutical Compounding Recalls Test PROCYP Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling Test PROCYP injectable vials because the company cannot guarantee the product is sterile.

    Product
    Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1262-2019·2019-05-08

    Customceutical Compounding Recalls TriMix MEDIUM Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling TriMix MEDIUM injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

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

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2019·2019-05-08

    Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity

    RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine impurity above acceptable levels.

    Product
    Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1226-2019·2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration

    DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.

    Product
    Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1255-2019·2019-05-08

    Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

    Product
    Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1257-2019·2019-05-08

    Customceutical Compounding Recalls Lipoplex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 16 vials of Lipoplex injectable compound because the sterility of the product cannot be assured.

    Product
    Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1258-2019·2019-05-08

    Customceutical Compounding Recalls Test D Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 8 vials of Test D compounded injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1253-2019·2019-05-08

    Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 32 vials of BPlex injectable compound because the product lacks assurance of sterility. The recall covers products distributed nationwide.

    Product
    BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1264-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

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

    Product
    Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1250-2019·2019-05-08

    Philips Fetal Spiral Electrode Recall Due to Metal Tip Breakage Risk

    Philips is recalling Fetal Spiral Electrodes because the metal tip may break off and remain in a newborn's scalp during delivery.

    Product
    Fetal Spiral Electrode, Model No. 9898 031 37631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1308-2019·2019-05-08

    Kingston Pharma Recalls Infant Cough Syrup Due to Microbial Contamination

    Kingston Pharma LLC is recalling DG health NATURALS infant cough syrup due to microbial contamination with Bacillus species. Consumers should stop using the product.

    Product
    DG health NATURALS For Infants 2+ Months+ baby Cough Syrup + Mucus, Natural Grape Flavor, 2 FL OZ (59 mL), UPC: 8 54954 00250 0, Product Code: 003
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1249-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

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

    Product
    Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1250-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 25 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1259-2019·2019-05-08

    Customceutical Compounding Recalls Test D Vials Due to Sterility Concerns

    Customceutical Compounding is recalling Test D vials because the manufacturer cannot ensure the injectable solution is sterile.

    Product
    Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1249-2019·2019-05-08

    Roche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops

    Roche Diagnostics is recalling 149 cobas e 801 immunoassay analyzers because signal drops after bottle changeovers may lead to incorrect medical decisions.

    Product
    cobas e 801 immunoassay analyzer
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1259-2019·2019-05-08

    GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue

    GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormal
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1240-2019·2019-05-08

    Philips MR Systems Recalled for Magnet Energization Device Electrical Shock Risk

    Philips is recalling four Ingenia Ambition MR systems because the Magnet Energization Device may have residual voltage, posing an electrical shock risk to personnel.

    Product
    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1311-2019·2019-05-08

    Iowa Corn Processors Recalls Yellow Corn Flour Due to Foreign Objects

    Iowa Corn Processors is recalling Yellow Corn Flour #600 Unenriched because it may contain pliable blue plastic. The product was distributed to distributors and processors in multiple states and internationally.

    Product
    Yellow Corn Flour #600 Unenriched, packaged in bulk and 50 lb bags
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1263-2019·2019-05-08

    GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue

    GE Healthcare is recalling six NM/CT 860 systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1315-2019·2019-05-08

    Fannie May Pixies Recalled for Missing Pecan Allergen Labeling

    Fannie May Confections Brands, Inc. is recalling Pixies Caramel and Pecan Clusters because the outer holiday wrap fails to declare pecans, a major allergen.

    Product
    Fannie May Pixies , Caramel and Pecan Clusters covered in Milk Chocolate 14 oz. Box - 12 units per case
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1225-2019·2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants

    DePuy Spine is recalling Concorde Lift spinal fusion implants due to a complaint trend of post-operative loss of height and migration.

    Product
    Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1314-2019·2019-05-08

    Tom Sturgis Little Ones Pretzels Recalled for Undeclared Milk Allergen

    Tom Sturgis Pretzels, Inc. is recalling Little Ones Pretzels because some bags contain a milk allergen not listed on the label.

    Product
    Little Ones Pretzels¿ 4.5lb, 1 polyethylene bag per corrugated container .
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1266-2019·2019-05-08

    GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue

    GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

    Product
    Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1251-2019·2019-05-08

    Advanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution

    Advanced Pharma Inc. is voluntarily recalling 560 bags of compounded Hydromorphone 20 mg/100 mL Injectable Solution due to sub-potency. The product was distributed nationwide in the US.

    Product
    HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1324-2019·2019-05-08

    Stanganellis Pumpkin Cake Roll Recalled for Missing Soy Allergen Labeling

    Spagel Brothers, Inc. is recalling Stanganellis Pumpkin Cake Roll because the packaging failed to list soy as an ingredient.

    Product
    Stanganellis Italian Foods, Pumpkin Cake Roll, Net Wt. 24 oz. . One pie per package . Box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1262-2019·2019-05-08

    GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue

    GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by v
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1312-2019·2019-05-08

    Caesar's Pasta Recalls Gluten-Free Gartin Due to Listeria or Salmonella Risk

    Caesar's Pasta, LLC is recalling Beecher's Gluten Free Kale and Rice Gartin because a sub-ingredient may be contaminated with Listeria monocytogenes or Salmonella.

    Product
    BEECHERS GLUTEN FREE KALE AND RICE GARTIN, Net wt. 20 Oz. (1lb. 4.0 oz ) 567 g / 9 cartons/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1261-2019·2019-05-08

    GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect

    GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1316-2019·2019-05-08

    Trader Joe's Saucy Scallops Recalled for Unlabeled Crustacean Allergen

    Frial SAS is recalling Trader Joe's Saucy Scallops with Mushrooms because the scallop flavor contains low levels of crustaceans not listed on the label.

    Product
    Trader Joe's Saucy Scallops with Mushrooms, NET Wt. 16 oz. (1 LB) 454 g UPC 0093 0390 24 units per case Product of France Dist. and sold exclusively by: Trader Joe's Monrovia, CA 91016
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1257-2019·2019-05-08

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of mounting redundancy.

    Product
    Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1247-2019·2019-05-08

    Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk

    Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1317-2019·2019-05-08

    Harmless Harvest Recalls Dairy-Free Yogurt Drink Due to Packaging Defect

    Harmless Harvest Inc. is voluntarily recalling specific lots of its Dairy-Free Yogurt Drink due to a packaging defect that may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink; Probiotic Original Unsweetened. 8 fl. oz. plastic bottle; UPC 859078-002962 USDA Organic
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1224-2019·2019-05-08

    Matrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is recalling 42 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2019·2019-05-08

    AmEx Pharmacy Recalls Bevacizumab Syringes Due to Defective Delivery System

    AmEx Pharmacy is recalling 249 syringes of Bevacizumab intravitreal injection because the delivery system is difficult to express.

    Product
    BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1275-2019·2019-05-08

    US Worldmeds Recalls Revonto Dantrolene Sodium Injection Due to Precipitate

    US Worldmeds LLC is recalling 6,456 vials of Revonto (dantrolene sodium for injection) because the reconstituted solution showed out-of-specification precipitate during stability testing.

    Product
    Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2019·2019-05-08

    GE Discovery NM/CT 670 ES Recalled for Potential Detector Screw Issue

    GE Healthcare is recalling three Discovery NM/CT 670 ES systems because detector screws may not have been secured correctly during installation.

    Product
    Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormali
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1245-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

    Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2019·2019-05-08

    GE Healthcare Recalls 27 NM/CT 870 DR Systems Due to Detector Screw Issue

    GE Healthcare is recalling 27 NM/CT 870 DR systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.

    Product
    NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1276-2019·2019-05-08

    American Health Packaging Recalls Glipizide Extended-Release Tablets for Dissolution Failure

    American Health Packaging is recalling 2,203 cartons of Glipizide Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications at time zero.

    Product
    GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.

    Product
    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1321-2019·2019-05-08

    Lamb Weston Recalls Potato Tater Puffs Due to Plastic Contamination

    Lamb Weston BSW LLC is recalling specific lots of Lamb's Supreme Potato Tater Puffs due to potential contamination with plastic objects.

    Product
    Lamb s Supreme Potato Tater Puffs, item # H30, packaged in 5-pound unprinted KRAFT paper bags, 6 bags to a case, sold as a foodservice item. UPC 1 00 44979 00830 5. The case label is read in parts: "***LAMB'S SUPREME TATER PUFFS***FROZEN POTATOES***6/5 LB BAGS***Produced by L
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Food)·F-1326-2019·2019-05-08

    Wawa Iced Tea Less Sugar Recalled for Missing Phenylketonuria Warning

    Wawa, Inc. is recalling Wawa Iced Tea Less Sugar bottles because the label fails to list the required phenylketonuria warning and does not identify Aspartame as an ingredient.

    Product
    Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019 (APR/29/19)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1244-2019·2019-05-08

    Siemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode

    Siemens is recalling 53 SOMATOM Confidence CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2019·2019-05-08

    GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect

    GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.

    Product
    Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medici
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1238-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1322-2019·2019-05-08

    Rice Valley Noodles Recalled for Undeclared Yellow 5 and 6 Dyes

    Rice Valley Foods is recalling Ready Cooked and Instant Noodles because FDA inspection found undeclared Yellow 5 and 6 dyes.

    Product
    Rice Valley Ready Cooked Noodles and Instant Noodles, Net Wt, 14 oz. plastic bag - Perishable, Keep Refrigerate UPC 9 92320 40305 3, UPC: 9 9230 40301 5 Made in USA Rice Valley Foods Company, San Francisco, CA 94124
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1318-2019·2019-05-08

    Harmless Harvest Recalls Strawberry Coconut Drink Due to Packaging Defect

    Harmless Harvest is voluntarily recalling specific lots of its Strawberry Probiotic Coconut Drink due to a packaging defect that may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink - Probiotic Strawberry. 8 fl. oz. plastic bottle; UPC 859078-002979
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1310-2019·2019-05-08

    Iowa Corn Processors Recalls Yellow Corn Flour Due to Plastic Contamination

    Iowa Corn Processors is recalling Yellow Corn Flour #620 because it may contain pliable blue plastic. The product was distributed to distributors and processors in multiple states and internationally.

    Product
    Yellow Corn Flour #620, Unenriched, packaged in bulk and 50 lb bags
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-1319-2019·2019-05-08

    Harmless Harvest Recalls Dairy-Free Yogurt Drinks Due to Packaging Defect

    Harmless Harvest Inc. is voluntarily recalling specific lots of Dairy-Free Yogurt Drinks due to a packaging defect that may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink: Probiotic Blueberry. 8 fl. oz. plastic bottle; UPC 859078-002986
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1255-2019·2019-05-08

    Randox G-6-PDH Normal Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 10 kits of G-6-PDH Normal Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1243-2019·2019-05-08

    Molnlycke Recalls EZ Derm Porcine Xenograft Due to Heat Seal Failures

    Molnlycke Health Care is recalling 1,332 units of EZ Derm Porcine Xenograft due to intermittent heat seal failures on the outer pouch.

    Product
    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2019·2019-05-08

    BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results

    BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.

    Product
    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with Fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2019·2019-05-08

    Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1246-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

    Siemens is recalling 53 SOMATOM Edge Plus CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1320-2019·2019-05-08

    Harmless Harvest Recalls Mango Yogurt Drinks Due to Packaging Defect

    Harmless Harvest is voluntarily recalling specific lots of its Mango Dairy-Free Yogurt Drink because a packaging defect may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink; Probiotic Mango. 8 fl. oz. plastic bottle; UPC 859078-002993
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1264-2019·2019-05-08

    GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue

    GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine syste
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1234-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2019·2019-05-08

    Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is voluntarily recalling 46 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2019·2019-05-08

    PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy

    PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2019·2019-05-08

    Bard Medical Recalls ArcticGel Pads Due to Adhesion Defects

    Bard Medical Division is recalling specific lots of ArcticGel Pads because the hydrogel may not adhere properly to the pad.

    Product
    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1256-2019·2019-05-08

    Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits

    Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.

    Product
    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1252-2019·2019-05-08

    Carolina Liquid Chemistries Recalls 14 Etha RGT. Kits for Quality Issues

    Carolina Liquid Chemistries is recalling 14 Etha RGT. Kits (Lot 11686) due to quality concerns. The recall is voluntary and has been terminated.

    Product
    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-1253-2019·2019-05-08

    Carolina Liquid Chemistries Recalls Ethyl Alcohol Assay Kits

    Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.

    Product
    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-1280-2019·2019-05-08

    Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling

    Advantice Health is recalling Dermoplast Anesthetic Spray canisters because some full cases contain cans labeled with an incorrect net weight of 2.75 oz instead of 2.0 oz.

    Product
    Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1279-2019·2019-05-08

    Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling

    Advantice Health is recalling Dermoplast Anesthetic Spray canisters because the label incorrectly states the net weight as 2.75 oz instead of 2.0 oz.

    Product
    Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·050-2019·2019-05-07

    Santa Fe Importers Recalls Chicken Meatballs for Undeclared Soy Allergen

    Santa Fe Importers is recalling ready-to-eat chicken meatballs because they contain soy, an undeclared allergen. No adverse reactions have been reported.

    Product
    Santa Fe Importers, Inc. — Santa Fe Importers, Inc. Recalls Ready-To-Eat Chicken Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·034-2019 EXP·2019-05-04

    Tyson Recalls Frozen Chicken Strips Due to Metal Contamination

    Tyson Foods is recalling approximately 11.8 million pounds of frozen chicken strips that may contain pieces of metal. The recall follows consumer complaints of foreign matter and oral injuries.

    Product
    Tyson Foods, Inc. — Tyson Foods, Inc. Recalls Chicken Strip Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide

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