The Recall Desk

Archive

August 2019 recalls

831 recalls were announced in August 2019.

What the numbers show

Critical
20
Severe
255
High
265
Moderate
248
Low
43

Of the 831 recalls this month scored against our rubric, 2% are Critical, 31% are Severe.

Which agencies issued them

101–200 of 831

  • ModerateFDA (Drugs)·D-1835-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2342-2019·2019-08-28

    Siemens MAGNETOM Aera MRI Devices Recalled for Quench Venting System Port Issue

    Siemens Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Drugs)·D-1823-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2069-2019·2019-08-28

    Nosh Organic Fruit & Protein Soft Oat Bars Recalled for Mold Contamination

    First Start Holdings is recalling Nosh Organic Fruit & Protein Soft Oat Bars due to potential mold contamination. Consumers should stop eating the product and return it to the store.

    Product
    Nosh Organic Fruit & Protein Soft Oat Bar; Blueberry & Banana. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) Ingredients: Organic Whole Grain Rolled Oats, Organic, Tapioca Syrup, Organic Sunflower Seed Protein, Organic Sunflower Oil, Organic Date Paste, Organic…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1827-2019·2019-08-28

    Medtech Recalls Clear Eyes Eye Drops Due to Quality Control Concerns

    Medtech Products is recalling Clear Eyes eye drops due to quality assurance concerns at the manufacturing facility. The recall covers 66,168 bottles distributed in the US, Puerto Rico, and several Caribbean nations.

    Product
    Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1831-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops

    Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to manufacturing quality control concerns.

    Product
    Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2327-2019·2019-08-28

    BD Max ExK TNA 2 Extraction Tube Kit Recall for Sealing Defects

    Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK TNA 2; Catalog # 442825
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1830-2019·2019-08-28

    Medtech Recalls Clear Eyes Itchy Eye Relief Due to Quality Control Issues

    Medtech Products is recalling 1,752 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2019·2019-08-28

    BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max ExK DNA 1 USA; Catalog # 442817
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1833-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls at the manufacturing facility.

    Product
    Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2019·2019-08-28

    Cambridge Sensors Recalls Microdot Xtra Blood Glucose Test Strips

    Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.

    Product
    Microdot Xtra blood glucose test strips
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1832-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Due to Quality Concerns

    Medtech Products is recalling 1,836 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2328-2019·2019-08-28

    BD MAX MRSA Reagent Kit Recall Due to Improperly Sealed Foil Bags

    Becton Dickinson is recalling 176 units of BD MAX MRSA Reagent Kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max MRSA; Catalog # 442953
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2347-2019·2019-08-28

    Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits

    Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1825-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops

    Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.

    Product
    Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2332-2019·2019-08-28

    BD Max StaphSR Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max StaphSR; Catalog # 443418
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1834-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Concerns

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.

    Product
    Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2019·2019-08-28

    BD MAX Reagent Extraction Tubes Recalled for Improper Sealing

    Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.

    Product
    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1828-2019·2019-08-28

    Medtech Recalls Clear Eyes Eye Drops Due to Quality Assurance Concerns

    Medtech Products, Inc. is recalling Clear Eyes eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2019·2019-08-28

    BD MAX Enteric Bacterial Panel Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD MAX Enteric Bacterial Panel kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2337-2019·2019-08-28

    Becton Dickinson Recalls BD Max Enteric Viral Panel Reagent Kits

    Becton Dickinson is recalling 27 units of BD Max Enteric Viral Panel RUO kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1822-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls at the manufacturing facility.

    Product
    Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2346-2019·2019-08-28

    Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues

    Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2335-2019·2019-08-28

    BD Max GC RT PCR Assay Recalled for Improperly Sealed Foil Bags

    Becton Dickinson is recalling BD Max GC RT PCR Assay kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max GC RT PCR Assay; Catalog # 443486
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2321-2019·2019-08-28

    BD Max Check-Points CPO IVD Kit Recalled for Improperly Sealed Foil Bags

    Becton Dickinson is recalling 130 units of BD Max Check-Points CPO IVD kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1824-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Drops

    Medtech Products is recalling Clear Eyes Maximum Itchy Eye Relief drops due to quality assurance concerns at the manufacturing facility.

    Product
    Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1826-2019·2019-08-28

    Medtech Recalls Clear Eyes Assorted Displays Due to Quality Control Concerns

    Medtech Products is recalling Clear Eyes Assorted IRC Displays due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2354-2019·2019-08-28

    Molded Products Recalls Mislabelled Luer Lock Sets for IV Administration

    Molded Products Inc is recalling 130,000 Luer Lock Sets (Catalog # MPC-125) because some packages were incorrectly labeled as a different product.

    Product
    Luer Lock Set - Catalog # MPC-125, for IV administration sets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2351-2019·2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Defect

    Siemens is recalling 70 ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2019·2019-08-28

    BD Max ExK DNA 2 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max ExK DNA 2 USA kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK DNA 2 USA; Catalog # 442819
    Category
    Medical Device
    Distribution
    38 states
  • LowFDA (Devices)·Z-2291-2019·2019-08-28

    FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 2,079 MICRO-TEMP LT heat therapy systems because updated warnings indicate that exceeding 40°C for extended periods may cause tissue damage.

    Product
    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E059000·2019-08-27

    Chrysler Recalls Mopar Rear Step Kits for 2019 Ram 1500 Trucks

    Chrysler is recalling Mopar Rear Step Kits for 2019 Ram 1500 trucks because they may contact the fuel tank in a rear crash, causing a leak and fire risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19188·2019-08-27

    Happy Plugs Recalls Wireless Headphones Due to Burn Hazard

    Happy Plugs is recalling Bluetooth Wireless II headphones because the included micro-USB charging cable can cause overheating and burns. No injuries have been reported.

    Product
    Happy Plugs Bluetooth Wireless II Headphones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·19773·2019-08-26

    BRP Recalls 2019 Ski-Doo Snowmobiles Due to Fuel Leak Fire Hazard

    BRP is recalling about 2,900 2019 Ski-Doo snowmobiles with 850 E-TEC engines because a fuel leak at the injector poses a fire hazard. Consumers should stop using the vehicles and contact a dealer for a free repair.

    Product
    2019 Ski-Doo snowmobiles equipped with an 850 E-TEC engine
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E057000·2019-08-26

    MAC Tools tire pressure gauges recalled due to inaccurate pressure readings

    Stanley Assembly Technologies is recalling certain MAC Tools tire pressure gauges because they may display lower than actual pressure when battery voltage is low, potentially causing tires to burst.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V623000·2019-08-26

    Lance Camper Recalls 2018-2019 855S Trailers Due to Fire Risk

    Lance Camper is recalling 2018-2019 855S trailers because a wire may contact the refrigerator burner box, increasing fire risk.

    Product
    LANCE CAMPER — LANCE CAMPER LANCE CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·086-2019·2019-08-24

    Olympia Meats Recalls Pork Sausage for Undeclared Pistachio Allergen

    Olympia Meats is recalling ready-to-eat pork sausage products because they contain undeclared pistachios, a known tree nut allergen.

    Product
    Olympia Provisions — Olympia Meats Recalls Ready-To-Eat Pork Sausage Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·19V615000·2019-08-22

    Volkswagen Recalls Vehicles Due to Ignition Key Removal Risk

    Volkswagen is recalling 679,027 vehicles because silicate buildup may allow the key to be removed when the transmission is not in Park, increasing the risk of a rollaway.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE, GOLF SPORTWAGEN, JETTA, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E056000·2019-08-22

    ZF Brake Calipers Recalled for Incorrect Assembly Fluid and Drag Risk

    ZF North America is recalling brake calipers that may contain incorrect assembly fluid, causing seals to swell and brakes to drag.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V618000·2019-08-22

    Peterbilt 337 and 348 Trucks Recalled for Steering Column Defect

    PACCAR is recalling 2019-2020 Peterbilt 337 and 348 trucks because a steering shaft weld may crack, causing loss of steering control.

    Product
    PETERBILT — PETERBILT 348, 337
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V620000·2019-08-22

    Thomas Built Minotour School Buses Recalled for Missing Backup Cameras

    Daimler Trucks North America is recalling 2019-2020 Thomas Built Minotour school buses because they may be missing backup cameras, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1995-2019·2019-08-21

    The Cookie Dough Cafe Recalls Chocolate Chip Edible Cookie Dough Bars

    The Cookie Dough Cafe is recalling 16,080 bars of chocolate chip edible cookie dough due to undeclared peanuts. The product was distributed in Illinois, Michigan, Pennsylvania, and South Carolina.

    Product
    The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholesale case. UPC: 850947006418
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1989-2019·2019-08-21

    Golden Macadamia Nuts Recalled Due to Salmonella Contamination

    Golden Peanut and Tree Nuts LLC is recalling 25 lb. boxes of Golden Macadamia Nuts because a customer found Salmonella during testing.

    Product
    Golden Macadamia Nuts Dry Roasted Style 4R-DM; 25 lb. cardboard box Product of Kenya Manufactured by Golden Peanut Company, LLC-Lodi 1230 S. Fairmont Ave. Lodi, Ca 95240
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1762-2019·2019-08-21

    Infusion Options Recalls Cytarabine Products Due to Sterility Concerns

    Infusion Options, Inc. is recalling Cytarabine products in New York due to a lack of assurance of sterility.

    Product
    Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1774-2019·2019-08-21

    ERBITUX Infusions Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling ERBITUX infusion bags in New York due to a lack of assurance of sterility.

    Product
    ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2064-2019·2019-08-21

    Fenwal Volumat MC Agilia Infusion Pump Software Recall

    Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.

    Product
    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2264-2019·2019-08-21

    Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1781-2019·2019-08-21

    Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.

    Product
    Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2066-2019·2019-08-21

    Medline Primary Warmer Pack Recalled for Unsafe Aluminum Levels

    Medline Industries is recalling 4,680 Primary Warmer Packs because the included Vyaire enFlow cartridge may release unsafe aluminum levels into the infusate.

    Product
    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1820-2019·2019-08-21

    American Health Packaging Recalls Aspirin and Dipyridamole Capsules

    American Health Packaging is recalling specific lots of Aspirin and Extended-release Dipyridamole Capsules due to an unknown impurity found in stability samples.

    Product
    Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1776-2019·2019-08-21

    Infusion Options Recalls Etoposide Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Etoposide infusion bags in New York due to a lack of assurance of sterility.

    Product
    Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; Etoposide 170 MG / 500 ml 0.9% NACL IVPB; Etoposide 152 MG / 500 ml 0.9% NACL IVPB; Etoposide 275 MG / 500 ml NS IVPB; Etoposide 270 MG / 500 ml NS IVPB; Etoposide 90 MG / 500 ml NS IVPB; Etoposide 160…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2261-2019·2019-08-21

    Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1800-2019·2019-08-21

    Infusion Options Recalls Paclitaxel Protein Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.

    Product
    PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1795-2019·2019-08-21

    Infusion Options Recalls OPDIVO Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling OPDIVO 200 mg and 480 mg infusion products in New York due to a lack of assurance of sterility.

    Product
    OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1994-2019·2019-08-21

    Mountain Rose Herbs Recalls Fennel Seed for Salmonella Risk

    Mountain Rose Herbs is recalling Fennel Whole Seed due to potential Salmonella contamination. The product was sold in the US and Canada.

    Product
    Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds, sold under Mountain Rose Herbs brand. The label is read in parts: "***Fennel Seed Whole ***NET WT *** Origin: Egypt *** MOUNTAIN ROSE…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V616000·2019-08-21

    Mack Recalls 2015 Pinnacle Trucks Due to Front Axle Fracture Risk

    Mack Trucks is recalling 2015 Pinnacle (CXU) vehicles because front steer axles may have missed a heat-treating step, potentially causing them to fracture and leading to a loss of vehicle control.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1748-2019·2019-08-21

    Infusion Options Recalls ALIMTA Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling ALIMTA 785 mg and 1000 mg intravenous infusion bags in New York due to a lack of assurance of sterility.

    Product
    ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1804-2019·2019-08-21

    Infusion Options Recalls Perjeta IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Perjeta 420 mg/250 mL IV bags in New York due to a lack of assurance of sterility.

    Product
    PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1756-2019·2019-08-21

    Infusion Options Recalls Carboplatin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Carboplatin infusion bags because the company cannot guarantee the products are sterile.

    Product
    CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1813-2019·2019-08-21

    Infusion Options Recalls SOLIRIS IV Products Due to Sterility Concerns

    Infusion Options, Inc. is recalling SOLIRIS 1200 mg and 900 mg IV products in New York due to a lack of assurance of sterility.

    Product
    SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1752-2019·2019-08-21

    Infusion Options Recalls Bevacizumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Bevacizumab infusion bags in New York due to a lack of assurance of sterility.

    Product
    BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1805-2019·2019-08-21

    Infusion Options Recalls Pertuzumab IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Pertuzumab IV bags in New York due to a lack of assurance of sterility.

    Product
    PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1780-2019·2019-08-21

    GAZYVA Infusion Recall Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling GAZYVA 100 mg and 900 mg infusion products in New York due to a lack of assurance of sterility.

    Product
    GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1787-2019·2019-08-21

    Infusion Options Recalls Irinotecan Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Irinotecan infusion products in New York due to a lack of assurance of sterility.

    Product
    IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1766-2019·2019-08-21

    Infusion Options Recalls Decitabine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Decitabine 40 mg/100 ml infusions in New York due to a lack of assurance of sterility.

    Product
    DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1778-2019·2019-08-21

    Infusion Options Recalls FOSAPREPITANT Due to Sterility Assurance Concerns

    Infusion Options, Inc. is recalling FOSAPREPITANT 150 mg/150 ml NS IVPB in New York due to a lack of assurance of sterility.

    Product
    FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1793-2019·2019-08-21

    Infusion Options Recalls Nivolumab IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Nivolumab IV bags in New York due to a lack of assurance of sterility.

    Product
    NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1758-2019·2019-08-21

    Infusion Options Recalls Cetuximab IV Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions in New York due to a lack of assurance of sterility.

    Product
    CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1808-2019·2019-08-21

    Infusion Options Recalls Remicade Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Remicade infusion bags in New York due to a lack of assurance of sterility.

    Product
    REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1794-2019·2019-08-21

    Infusion Options Recalls Ondansetron Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Ondansetron 8 mg/50 mL infusions in New York due to a lack of assurance of sterility.

    Product
    ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1753-2019·2019-08-21

    Infusion Options Recalls Bleomycin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Bleomycin 18 Units / 100 mL NS IVPB products in New York due to a lack of assurance of sterility.

    Product
    BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V614000·2019-08-21

    Volkswagen Recalls 2019 Atlas Vehicles Due to Fuel Tank Weld Defect

    Volkswagen is recalling 2019 Atlas vehicles because a fuel tank weld defect may cause fuel leaks or engine stalling, increasing fire and crash risks.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1786-2019·2019-08-21

    Infusion Options Recalls Injectafer IV Products Due to Sterility Concerns

    Infusion Options, Inc. is recalling Injectafer 720 mg and 210 mg IV products in New York due to a lack of assurance of sterility.

    Product
    INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1792-2019·2019-08-21

    Infusion Options Recalls Mitomycin Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling Mitomycin 10 mg/20 mL IVP syringes in New York due to a lack of assurance of sterility.

    Product
    MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1790-2019·2019-08-21

    Infusion Options Recalls Methotrexate Injections Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Methotrexate injection products in New York due to a lack of assurance of sterility.

    Product
    METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE 98 MG / 3.92 ML IM SYR; METHOTREXATE 55 MG / 2.2 ML IVP; METHOTREXATE 59.5 MG / 2.38 ML IVP; METHOTREXATE 12 mg QS 6 ml 0.9% NACL; METHOTREXATE 150 MG / 50 ML NS IVPB; METHOTREXATE 112.5 MG…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1810-2019·2019-08-21

    Infusion Options Recalls Rituximab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific Rituximab infusion bags in New York due to a lack of assurance of sterility.

    Product
    RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 1000 MG / 1000 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1814-2019·2019-08-21

    Infusion Options Recalls Topotecan Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Topotecan 1.24 mg/100 mL infusions in New York due to a lack of assurance of sterility.

    Product
    TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1746-2019·2019-08-21

    Adcetris IV Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Adcetris 96 mg/100 mL IV infusion bags due to a lack of assurance of sterility. The product was distributed in New York.

    Product
    Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1744-2019·2019-08-21

    Infusion Options Recalls Oxytocin IV Solution Due to Sterility Concerns

    Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers IV Solution because the product lacks assurance of sterility. The recall affects 820 bags distributed in New York.

    Product
    Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1797-2019·2019-08-21

    Infusion Options Recalls Oxaliplatin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling multiple lots of oxaliplatin infusion bags due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2260-2019·2019-08-21

    Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1763-2019·2019-08-21

    Infusion Options Recalls Dacarbazine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Dacarbazine infusions in New York due to a lack of assurance of sterility.

    Product
    DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1765-2019·2019-08-21

    Infusion Options Recalls DARZALEX Infusion Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV infusion bags in New York due to a lack of assurance of sterility.

    Product
    DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1772-2019·2019-08-21

    Infusion Options Recalls Durvalumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Durvalumab infusions in New York due to a lack of assurance of sterility.

    Product
    Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2067-2019·2019-08-21

    Medline Centurion Convenience Kits Recalled for Infusion Set Defect

    Medline is recalling Centurion Convenience Kits containing BD Alaris Pump Infusion Sets due to a tubing defect that may cause over-infusion of medication.

    Product
    Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1768-2019·2019-08-21

    Infusion Options Recalls Diphenhydramine Infusion Due to Sterility Concerns

    Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS infusions in New York due to a lack of assurance of sterility.

    Product
    DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state

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