The Recall Desk

Archive

August 2019 recalls

831 recalls were announced in August 2019.

What the numbers show

Critical
20
Severe
249
High
270
Moderate
249
Low
43

Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.

101–200 of 831

  • 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-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 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-2339-2019·2019-08-28

    BD Max Enteric Viral Panel EU Extraction Tube Sealing Defect

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

    Product
    Kit BD Max Enteric Viral Panel EU Catalog # 443985
    Category
    Medical Device
    Distribution
    38 states
  • 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 (Devices)·Z-2331-2019·2019-08-28

    BD MAX Reagent Extraction Tube Foil Bags Recall

    Becton Dickinson is recalling BD MAX Reagent extraction tube kits because foil bags may not be sealed properly.

    Product
    Kit BD Max CT/GC/TV; Catalog # 442970
    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 (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 (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-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 Medt
    Category
    Drug
    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 EYE
    Category
    Drug
    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
  • 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-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 (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-2329-2019·2019-08-28

    BD Max Enteric Parasite Panel EU Extraction Tube Sealing Defect

    Becton Dickinson is recalling BD Max Enteric Parasite Panel EU kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
    Category
    Medical Device
    Distribution
    38 states
  • 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-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 7811
    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 (Drugs)·D-1829-2019·2019-08-28

    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 Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 Dri
    Category
    Food
    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 (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 (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-2334-2019·2019-08-28

    BD Max MRSA XT Extraction Tube Sealing Defect Recall

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

    Product
    Kit BD Max MRSA XT; Catalog # 443461
    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%, Naphazo
    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 (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); Distrib
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2019·2019-08-28

    Pro-Dex Surgical Driver Battery Packs Recalled for Visual Particulates

    Pro-Dex Inc is recalling sterile surgical driver battery packs due to visual particulates found within the Tyvek pouches.

    Product
    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 by
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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·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
  • 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
  • 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·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
  • 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
  • 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-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
  • 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
  • SevereFDA (Devices)·Z-2265-2019·2019-08-21

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

    Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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 bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-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-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/ 4
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2267-2019·2019-08-21

    Smith & Nephew Wound Drain Recall Due to Breakage Risk

    Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.

    Product
    Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 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 flu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1775-2019·2019-08-21

    Infusion Options Recalls Eribulin Infusions Due to Sterility Concerns

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

    Product
    ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBULIN 1.89 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-1789-2019·2019-08-21

    Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.

    Product
    LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml D5
    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; CARBOPLA
    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 M
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1745-2019·2019-08-21

    Infusion Options Recalls Abraxane Infusions Due to Sterility Concerns

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

    Product
    Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 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-1798-2019·2019-08-21

    Infusion Options Recalls Paclitaxel Infusions Due to Sterility Concerns

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

    Product
    PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG / 25
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1771-2019·2019-08-21

    Infusion Options Recalls Doxorubicin Liposomal Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions in New York due to a lack of assurance of sterility.

    Product
    Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1779-2019·2019-08-21

    Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns

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

    Product
    Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil 3920 MG QS 92 ML 0.9% NACL Fluorouracil 3760 mg QS 100 ml NS CASS Fluorouracil 4000 MG QS 92 ml 0.9% NACL Fluorouracil 3140 MG QS 240 ML NS PUMP Fluorouracil 2400 MG QS 96 ML 0.9% NACL F
    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 D5W
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1747-2019·2019-08-21

    Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns

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

    Product
    ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB EMTA
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1760-2019·2019-08-21

    Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS
    Category
    Drug
    Distribution
    1 state
  • 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 MG
    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
  • 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-1811-2019·2019-08-21

    Infusion Options Recalls RomiPLOStim Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling RomiPLOStim 700 MCG/1.4 ML SQ syringes in New York due to a lack of assurance of sterility.

    Product
    RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    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 Dispo
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2266-2019·2019-08-21

    Medline Silicone Drain Recalled for Risk of Breaking During Use

    Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB 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 body cavi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1802-2019·2019-08-21

    Panitumumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PANITUMUMAB 400 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 HERB
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 intermitt
    Category
    Medical Device
    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-1770-2019·2019-08-21

    Infusion Options Recalls Doxorubicin Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Doxorubicin IV syringes in New York due to a lack of assurance of sterility.

    Product
    Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG / 46.5 ML IV SYRINGE; Doxorubicin 112 MG / 56 ML IVP SYRINGE; Doxorubicin 50 MG / 25 ML IVP SYRINGE;
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1767-2019·2019-08-21

    Infusion Options Recalls Dexamethasone Infusions Due to Sterility Concerns

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

    Product
    DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 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 (Devices)·Z-2065-2019·2019-08-21

    Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software

    Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.

    Product
    Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1803-2019·2019-08-21

    Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns

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

    Product
    PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 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-1788-2019·2019-08-21

    Iron Sucrose Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    IRON SUCROSE 200 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-1749-2019·2019-08-21

    Atezolizumab Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Atezolizumab 1200 mg/250 mL in New York due to a lack of assurance of sterility.

    Product
    ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1773-2019·2019-08-21

    Entyvio Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.

    Product
    ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    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
  • SevereFDA (Drugs)·D-1807-2019·2019-08-21

    Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns

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

    Product
    RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 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-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
  • 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 (Drugs)·D-1816-2019·2019-08-21

    Infusion Options Recalls Velcade Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Velcade subcutaneous syringes in New York due to a lack of assurance of sterility.

    Product
    VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg / 0.6
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1750-2019·2019-08-21

    Infusion Options Recalls Avastin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Avastin infusion products because of a lack of assurance of sterility. The recall is limited to New York.

    Product
    AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2263-2019·2019-08-21

    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, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 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, dr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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