The Recall Desk

Archive

February 2023 recalls

503 recalls were announced in February 2023.

What the numbers show

Critical
6
Severe
69
High
395
Moderate
32
Low
1

Of the 503 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

1–100 of 503

  • SevereNHTSA·23V132000·2023-02-28

    Hyundai Recalls 2012-2014 Veloster Vehicles Due to Electrical Fire Risk

    Hyundai is recalling 2012-2014 Veloster vehicles because high conductive liquid may leak into the Reverse Park Aid Sensor, causing an electrical short circuit and increasing fire risk.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V131000·2023-02-28

    2023 Nissan Ariya recalled for potentially loose steering wheel bolts

    Nissan North America is recalling 2023 Ariya vehicles with potentially loose or missing steering wheel bolts. A detached steering wheel could cause loss of steering control and increase crash risk.

    Product
    NISSAN — NISSAN redundant ARIYA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V129000·2023-02-27

    Royal Enfield Himalayan motorcycles recalled for brake caliper corrosion

    Royal Enfield is recalling 2017-2021 Himalayan motorcycles because road salt may corrode brake calipers, potentially causing brake failure and increasing crash risk.

    Product
    ROYAL ENFIELD — ROYAL ENFIELD HIMALAYAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V130000·2023-02-27

    Tesla Recalls 2022-2023 Model Y Vehicles for Loose Seat Bolts

    Tesla is recalling 2022-2023 Model Y vehicles because second-row seat back frame bolts may not be securely tightened, potentially reducing seat belt performance.

    Product
    TESLA — TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V128000·2023-02-24

    2023 Ford Expedition front axle may fracture, increasing crash risk

    Ford is recalling certain 2023 Expeditions, along with F-150 and Lincoln Navigator vehicles, due to a front axle pinion defect that may not have been properly heat-treated. The defect can cause fracture, loss of 4-wheel drive, and wheel lockup, increasing crash risk.

    Product
    FORD — FORD, LINCOLN F-150, EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V121000·2023-02-24

    Thor Motor Coach recreational vehicles recalled for detaching overhead cabinets

    Thor Motor Coach is recalling 2018-2021 Windsport and Hurricane recreational vehicles because the driver and front passenger overhead cabinets may detach while in motion, risking injury to occupants.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH HURRICANE, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V126000·2023-02-24

    Prevost Recalls Motor Coaches Due to Fire Suppression Sensor Defect

    Prevost is recalling 2018-2023 H3-45 and 2019 H3-41 vehicles because a fire sensor may corrode, causing sudden engine shutdown and crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45, H3-41
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V123000·2023-02-24

    2023 BMW S 1000 RR Motorcycles Recalled for Hand Brake Defect

    BMW of North America is recalling certain 2023 S 1000 RR motorcycles due to a hand brake lever defect that may reduce brake performance. Approximately 394 units are affected.

    Product
    BMW — BMW S 1000 RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·23136·2023-02-23

    LumaRail Bed Assist Rails recalled for entrapment and asphyxia hazard

    Platinum Health is recalling about 53,000 LumaRail bed assist rails because users can become entrapped between the rail and mattress, risking death by asphyxiation. One death has been reported.

    Product
    LumaRail Bed Assist Rails
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V120000·2023-02-23

    2022–2024 International and IC Bus Trucks/Buses: Engine Control Software Defect

    Navistar is recalling 2022-2024 International HV and MV trucks and 2022-2023 IC Bus TC buses. An engine control module software defect can cause the engine to override the parking brake when the transmission remains in drive or reverse and the power take-off switch is engaged, resulting in unintended vehicle movement.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS MV, TC, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V117000·2023-02-23

    Braun Recalls Demers Ambulances Due to Rear Step Welding Defect

    Braun Ambulances is recalling specific 2020 and 2022 Demers ambulances because the rear step may fail under weight due to incorrect welding, posing an injury risk.

    Product
    DEMERS — DEMERS MXP150E, MXP170E, MXP170Z, MXP170MLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V118000·2023-02-23

    2022-2023 BMW M3 Door Locking Software Defect Recall

    BMW is recalling certain 2022-2023 models due to a door locking software defect. Faulty ECU programming may prevent doors from locking while driving, increasing crash injury risk.

    Product
    BMW — BMW I4, M440I, M340I, 430I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V113000·2023-02-23

    2015–2023 Thor Motor Coach Palazzo Front Brackets May Detach While Driving

    Thor Motor Coach is recalling 1,969 Palazzo recreational vehicles from model years 2015–2023 because front brackets supporting the fiberglass panel may become loose and detach while driving, creating a road hazard.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH PALAZZO, redundant PALAZZO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23132·2023-02-23

    Zinus SmartBase Euro Slats Metal Platform Bed Frames Recalled for Collapse Hazard

    Zinus is recalling about 30,400 SmartBase Euro Slats metal platform bed frames because missing reinforcing brackets can cause the frame to collapse, creating an injury hazard. Consumers should stop using the bed frames and request a free repair kit.

    Product
    SmartBase® Euro Slats Metal Platform Bed Frames
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23135·2023-02-23

    Aderes Bookcases Recalled Due to Tip-Over and Entrapment Hazards

    TJX is recalling about 73 Aderes bookcases that can tip over if not anchored to the wall, posing tip-over and entrapment hazards that can result in death or injuries to children. Two reports of unstable bookcases have been received with no injuries reported.

    Product
    Aderes bookcases
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23134·2023-02-23

    Lancaster Table & Seating High Chairs Recalled for Fall Hazard

    Clark Associates is recalling Lancaster Table & Seating brand high chairs that can break during use, posing a fall hazard to children. Three reports of high chairs breaking have been received, though no injuries have been reported.

    Product
    Lancaster Table & Seating brand High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V119000·2023-02-23

    International commercial trucks recalled for park brake software defect

    Navistar is recalling 2018-2022 International trucks with a software defect that may prevent the park brake from holding during power-take-off operation, risking unexpected vehicle movement.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV, RH, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23129·2023-02-23

    Mainstays Three-Wick Candles Recalled for Fire and Laceration Hazards

    Star Soap Star Candle Prayer Candle recalled about 1.2 million Mainstays Three-Wick Candles because the wicks can burn too close to the glass container, causing it to break and posing fire and laceration hazards. Consumers should stop using the candles immediately and request a refund.

    Product
    Mainstays Three-Wick Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V115000·2023-02-23

    2021-2023 Dodge Durango Recalled for Misaligned Rear Spoiler Detachment Risk

    Chrysler is recalling 2021-2023 Dodge Durango vehicles because the rear spoiler may not be properly aligned with the roof. The misaligned spoiler can be damaged during liftgate use and potentially detach, becoming a road hazard.

    Product
    DODGE — DODGE DURANGO1, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23133·2023-02-23

    1st Stage Scuba Regulators Recalled for Drowning and Injury Risk

    XDEEP 1st stage scuba regulators (model NX700) are recalled because a defective screw on the turret connection can break, creating a risk of severe injury and drowning for divers.

    Product
    1st stage scuba regulators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02232023-001·2023-02-23

    New Seasons Pizza Sauce Recalled for Undeclared Allergens and Misbranding

    USDA FSIS issued a public health alert for New Seasons pizza sauce containing undeclared anchovies, milk, beef, and sulfites. Consumers should discard the product.

    Product
    Heritage Specialty Foods, LLC — FSIS Issues Public Health Alert for New Seasons Pizza Sauce Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighCPSC·23130·2023-02-23

    Two Million Cosori Air Fryers Recalled for Fire and Burn Hazards

    Atekcity Corporation is recalling about 2 million Cosori air fryers because a wire connection can overheat, posing fire and burn hazards. The firm has received 205 reports of fires, with 10 minor burn injuries and 23 reports of minor property damage.

    Product
    Cosori Air Fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23728·2023-02-23

    Polaris Timbersled Snow Bike Conversion Kits Recalled for Crash Hazard

    Polaris is recalling about 780 Timbersled snow bike conversion kits because a QuickDrive fastener can loosen during operation, causing brake failure and crash risk. No crashes or injuries have been reported.

    Product
    Polaris Timbersled Snow Bike Conversion Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23131·2023-02-23

    SCARPA F1 Ski Boots Recalled for Fall Hazard

    SCARPA North America is recalling about 770 F1 LT and F1 GT ski boots manufactured in 2022. Screws attaching the ski/walk mechanism can loosen or fall out, causing the mechanism to malfunction and posing a fall hazard.

    Product
    F1 LT and F1 GT Ski Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23729·2023-02-23

    Harbor Freight Replacement Lower Blade Guards for 12-Inch Miter Saws

    Harbor Freight Tools is recalling replacement lower blade guards for 12-inch Chicago Electric Miter Saws because they do not sufficiently cover the saw blade and can break during use, posing an injury hazard.

    Product
    Replacement lower blade guards for 12-inch Chicago Electric Miter Saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V110000·2023-02-22

    2023 Lucid Air propulsion system electrical switches may fail unexpectedly

    Lucid is recalling certain 2022-2023 Air vehicles because electrically activated contactor switches in the propulsion system may unexpectedly open, cutting power to the electric motors and increasing the risk of a crash.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0349-2023·2023-02-22

    Wegmans Asian Chop Salad Kit recalled for undeclared milk and eggs

    Wegmans Asian Chop Salad Kit may contain undeclared milk and eggs. Consumers with these allergies should not consume this product and should seek a refund or discard it.

    Product
    Wegmans Asian Chop Salad Kit Net Wt. 13 OZ (368 g) Bag code date: TFMD013A5B. UPC: 077890512838.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0308-2023·2023-02-22

    Morphine Sulfate Intravenous Solutions Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions (1 mg/mL and 5 mg/mL) distributed nationwide due to lack of sterility assurance. The products may not be sterile, creating a potential risk of infection.

    Product
    MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2023·2023-02-22

    iTotal Identity Impactor Handle surgical screws may loosen during procedures

    Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.

    Product
    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2023·2023-02-22

    Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise

    Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.

    Product
    Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0297-2023·2023-02-22

    Antibiotic Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling an antibiotic injectable medication due to lack of sterility assurance. Seven bags were dispensed to patients nationwide with a Beyond Use Date of December 2022.

    Product
    IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2023·2023-02-22

    Surgical kits recalled due to compromised sterile wrapping

    Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Compromised Sterility of External Wrapping

    Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.

    Product
    Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PROD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0304-2023·2023-02-22

    Methadone Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling methadone syringes due to lack of sterility assurance. The affected product was dispensed to patients nationwide.

    Product
    METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2023·2023-02-22

    EVOLUTION MP Tibial Base knee component recalled for wrong product in packaging

    MicroPort Orthopedics is recalling EVOLUTION MP Tibial Base knee prosthesis components due to a packaging error where a wrong-sized component was placed inside product boxes. One incident was discovered during surgery.

    Product
    EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0307-2023·2023-02-22

    FDA recalls Milrinone injectable medication due to lack of sterility assurance

    Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.

    Product
    Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2023·2023-02-22

    Olympus colonovideoscope recalled for potential microbial contamination from veterinary use

    An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.

    Product
    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0278-2023·2023-02-22

    Cefazolin Antibiotic Injections Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Cefazolin antibiotic injections due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed nationwide.

    Product
    CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2023·2023-02-22

    Vitamin K Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Vitamin K (Phytonadione) 2.5mg injectable syringes distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0281-2023·2023-02-22

    Cefoxitin injectable bags recalled nationwide for sterility assurance failure

    Cefoxitin injectable antibiotic (1GM and 2GM) prepared by Sentara Infusion Services is being recalled nationwide due to lack of sterility assurance. Affected patients should contact their pharmacy immediately.

    Product
    CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0303-2023·2023-02-22

    Meropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 91 bags of meropenem injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients.

    Product
    MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0310-2023·2023-02-22

    Nafcillin Antibiotic Infusion Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling 16 bags of nafcillin antibiotic infusion nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.

    Product
    NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2023·2023-02-22

    Abelcet Injectable Drug Recalled Due to Bacterial Contamination

    A sterile injectable drug, Abelcet, is being recalled due to bacterial contamination detected in a nationwide shipment. The recall affects 31,879 vials with lot number 1203A.

    Product
    Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0305-2023·2023-02-22

    Methylprednisolone steroid injections recalled for lack of sterility assurance

    Sentara Infusion Services is recalling 27 syringes of Methylprednisolone steroid due to lack of sterility assurance. The product was distributed nationwide to patients with a beyond-use date of December 29-31, 2022.

    Product
    Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2023·2023-02-22

    Ampicillin IV Infusion Bags Recalled for Lack of Sterility Assurance

    Sentara Home Infusion Pharmacy Services is recalling 14 bags of Ampicillin 8GM in NS 400ML due to lack of sterility assurance. The affected batches were distributed nationwide to patients.

    Product
    AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2023·2023-02-22

    Cefepime injectable antibiotic bags recalled due to sterility concerns

    Sentara Infusion Services is recalling 71 bags of Cefepime injectable antibiotic due to lack of sterility assurance. Patients who received affected doses should consult their healthcare provider.

    Product
    CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0293-2023·2023-02-22

    Fluconazole 200mg injection recalled due to sterility concerns

    Sentara Infusion Services is recalling Fluconazole 200mg injectable solution due to lack of sterility assurance. The recall affects 13 bags distributed nationwide to patients.

    Product
    FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2023·2023-02-22

    Ertapenem Injectable Antibiotic Bags Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 22 bags of Ertapenem (Invanz) injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving home infusion therapy.

    Product
    Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0298-2023·2023-02-22

    INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0306-2023·2023-02-22

    Metronidazole injectable antibiotic recalled due to sterility concerns

    Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg injectable antibiotic distributed nationwide due to lack of sterility assurance. Patients using the product should contact their healthcare provider.

    Product
    METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0356-2023·2023-02-22

    Vietnamese Coffee Cheesecake Recalled for Undeclared Coconut Allergen

    A Vietnamese Coffee Cheesecake product from Hood Famous Bake Shop is being recalled because coconut is listed in the ingredients but not in the allergen declaration, posing a risk to those with coconut allergies.

    Product
    Vietnamese Coffee Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37080 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0355-2023·2023-02-22

    White Chocolate Guava Cheesecake Recalled for Undeclared Soy and Coconut

    Amlag & Quibuyen, LLC is recalling White Chocolate Guava Cheesecake (4oz) because soy lecithin and coconut are not declared on the label, risking exposure for allergic consumers.

    Product
    White Chocolate Guava Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37077 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0273-2023·2023-02-22

    Amikacin Injectable Antibiotic Lacks Sterility Assurance, Nationwide Recall

    Sentara Infusion Services is recalling 7 bags of Amikacin 450MG injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving IV infusions.

    Product
    Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0350-2023·2023-02-22

    Lemon Almond Blueberry Bread recalled for undeclared soy lecithin

    Heidi Remington is recalling 76 packages of Lemon Almond Blueberry Bread distributed in Oregon due to undeclared soy lecithin in a releasing agent spray. Soy is a major allergen posing risk to consumers with soy allergies.

    Product
    Lemon Almond Blueberry Bread, UPC 7 21762 76434 3, Net wt.3.5oz (98g). The sliced Lemon Blueberry Bread is wrapped in a clear plastic shrink wrap. The label stated "***Lemon Almond Blueberry Bread* Malted barley wheat flour, milk, eggs, almonds...Contains: Wheat, eggs, milk, almo
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0354-2023·2023-02-22

    Ube Cheesecake Recalled for Undeclared Coconut Allergen

    Hood Famous Bake Shop is recalling Ube Cheesecake products because coconut is listed in ingredients but not declared in the allergen statement, posing a risk to consumers allergic to coconut.

    Product
    Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37067 8. Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (2 lbs.) - UPC 6 60845 37068 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0269-2023·2023-02-22

    Metoprolol Succinate ER Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications that may prevent proper drug release.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2023·2023-02-22

    FDA Class II: TPN solution bags lack sterility assurance

    Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution due to lack of sterility assurance. Products were dispensed nationwide to patients.

    Product
    TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ;
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2023·2023-02-22

    HydroPICC Catheter Recall Due to Incorrect Expiration Dates on Select Lots

    Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.

    Product
    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0353-2023·2023-02-22

    Brittle Products Recalled for Undeclared Soy Allergen

    Brittle Brothers LLC is recalling multiple brittle products due to undeclared soy allergen distributed in Tennessee. Consumers with soy allergies who may have purchased these products should not consume them.

    Product
    Peanut Brittle, Cashew Brittle, Pecan Brittle, Bacon Brittle, Nashville Hot Brittle 5 oz, 8 oz, 16oz and bulk packaging
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0286-2023·2023-02-22

    Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.

    Product
    DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2023·2023-02-22

    Coconut Pandan Cheesecake Recalled for Undeclared Sulfite and Coconut Allergens

    Hood Famous Bake Shop is recalling Coconut Pandan Cheesecake because sulfite and coconut allergens are not declared on the label. Consumers with allergies should not consume this product.

    Product
    Coconut Pandan Cheesecake Coconut Butter Biscuit Crust (4oz) - 6 60845 37071 5.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V111000·2023-02-22

    2022-2023 Toyota Tundra Instrument Panel Display Software Error

    Toyota is recalling 2022-2023 Tundra and Tundra Hybrid vehicles due to a software error that may cause the instrument panel display to go blank. This prevents drivers from seeing critical information like the speedometer and warning lights.

    Product
    TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0312-2023·2023-02-22

    Ondansetron 8mg Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling ondansetron 8mg injectable doses due to lack of sterility assurance. The medication was dispensed to patients nationwide with a beyond use date of December 29-30, 2022.

    Product
    ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0351-2023·2023-02-22

    El Tapatio Queso Fresco Cheese Recalled Due to Missing Ingredient Statement

    El Tapatio Queso Fresco cheese is being recalled because the product lacks a required ingredient statement on its packaging. This prevents consumers, especially those with food allergies, from identifying potential allergens.

    Product
    El Tapatio Queso Fresco, Mexican Style Crumbling Cheese. Item 5204. UPC 0 83846-10158 2. Net Wt. 10 oz. (283g). Keep Refrigerated. Manufacture for: La Hispamex Food Products, Inc., Cicero, IL 60804.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0302-2023·2023-02-22

    Levothyroxine Injectable Syringes Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling levothyroxine injectable syringes dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if they received this product.

    Product
    LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2023·2023-02-22

    Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect

    Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2023·2023-02-22

    Potential Gantry Locking Mechanism Defect in SIEMENS Biograph mCT PET Scanners

    The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.

    Product
    SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2023·2023-02-22

    Surgical convenience kits recalled for sterile barrier defect

    Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.

    Product
    Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Non-Sterile Outer Wrapping

    MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0271-2023·2023-02-22

    FDA Recalls Maximum Zone2 Topical Analgesic Due to Epinephrine Discoloration

    HTO Nevada's Maximum Zone2 Topical Analgesic (1oz, Lot #795CP-0003, NDC 80069-012-01) is recalled nationwide in the USA and Canada due to discoloration of the epinephrine active ingredient caused by a manufacturing deviation.

    Product
    Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2023·2023-02-22

    Dobutamine Injectable Medication Recalled Due to Lack of Sterility Assurance

    Dobutamine injectable medication distributed by Sentara Infusion Services has been recalled due to lack of sterility assurance. If you received this medication, contact your healthcare provider for guidance.

    Product
    DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2023·2023-02-22

    Hydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.

    Product
    HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0292-2023·2023-02-22

    Ethanol 70% Syringes Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 17 units of ETHANOL 70% 0.5ML syringes distributed nationwide due to lack of sterility assurance. The syringes may not meet required sterility standards for safe injection.

    Product
    ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0276-2023·2023-02-22

    Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns

    Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.

    Product
    Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0270-2023·2023-02-22

    New & Improved Blue Gel Anesthetic Recalled Nationwide for API Discoloration

    HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic nationwide due to discoloration of the epinephrine active pharmaceutical ingredient resulting from a cGMP deviation in the raw material supply.

    Product
    New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingre
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0352-2023·2023-02-22

    Starbucks Vanilla Frappuccino Recalled for Potential Glass Contamination

    PepsiCo is recalling Starbucks Vanilla Frappuccino bottles nationwide due to potential glass contamination. Consumers should not consume affected bottles.

    Product
    Starbucks frappuccino Vanilla. Chilled Coffee Drink. 13.7 Fl Oz (405mL). UPC 0 12000-81331 3. Starbucks Coffee Company. For comments or questions, call 1-800-211-8307.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2023·2023-02-22

    Sentara TPN Products Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 26 bags of Total Parenteral Nutrition (TPN) solutions distributed nationwide because the manufacturer cannot assure the products maintain sterility. Patients receiving these products should contact their healthcare provider.

    Product
    TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeak
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0267-2023·2023-02-22

    Injectable Vitamin B Vials Recalled for Particulate Matter Contamination

    McGuff Compounding Pharmacy recalls 255 vials of thiamine and riboflavin injection nationwide due to foreign substances found in some vials.

    Product
    Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Sa
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0289-2023·2023-02-22

    Diphenhydramine 18mg Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.

    Product
    Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2023·2023-02-22

    Vancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue

    Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.

    Product
    VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V109000·2023-02-22

    2022 Rivian R1S and R1T passenger air bag deployment failure

    A faulty seat belt sensor in 2022 Rivian R1S and R1T vehicles may suppress or prevent air bag deployment during a crash. Affected owners should contact Rivian customer service at 1-888-748-4261 for a free replacement.

    Product
    RIVIAN — RIVIAN R1T, R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0321-2023·2023-02-22

    FDA Recalls TPN Nutrition Bags Due to Sterility Assurance Failure

    Sentara Infusion Services recalls 24 bags of TPN (Total Parenteral Nutrition) distributed nationwide due to lack of sterility assurance. The recall affects prescription intravenous nutrition products.

    Product
    TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0313-2023·2023-02-22

    FDA Recalls Pantoprazole Injectable Syringes for Sterility Assurance Failure

    Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0266-2023·2023-02-22

    Injectable drug vials recalled for particulate matter contamination

    McGuff Compounding Pharmacy Services is recalling Thiamine Hydrochloride and Riboflavin injection vials due to presence of foreign substances in some units.

    Product
    Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Service
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0296-2023·2023-02-22

    Hydromorphone Infusion Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Hydromorphone injectable solutions due to lack of sterility assurance. The recall affects 37 bags distributed nationwide.

    Product
    HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0301-2023·2023-02-22

    Levaquin 750MG Injectable Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.

    Product
    Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2023·2023-02-22

    SIEMENS Biograph Horizon 3R Mobile PET gantry locking mechanism defect

    Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.

    Product
    SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2023·2023-02-22

    Tobramycin 660mg Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Tobramycin 660mg injectable antibiotic used for home infusion therapy due to lack of sterility assurance. Two bags were dispensed to patients nationwide.

    Product
    TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0314-2023·2023-02-22

    Penicillin Intravenous Antibiotic Recalled Over Lack of Sterility Assurance

    Sentara Infusion Services is recalling eight bags of intravenous penicillin antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0272-2023·2023-02-22

    FDA Recalls 0.9% Sodium Chloride Solution for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 114 bags of 0.9% Sodium Chloride intravenous solution due to lack of sterility assurance. The product was distributed nationwide with Beyond Use dates of December 24–31, 2022.

    Product
    0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V112000·2023-02-22

    Roadtrek Recreational Vehicle Cooktop Recall: Gas Leak Fire Risk

    Roadtrek is recalling certain 2021-2022 recreational vehicles equipped with SDS2 2-burner cooktops because internal burner tubes may fracture and leak gas, creating a fire hazard.

    Product
    ROADTREK — ROADTREK ZION SLUMBER, PLAY SLUMBER, ZION, ZION SRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0311-2023·2023-02-22

    Nalbuphine Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0315-2023·2023-02-22

    Piperacillin/Tazobactam Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections due to lack of sterility assurance. The 78-unit recall affects patients nationwide.

    Product
    PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, C
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2023·2023-02-22

    Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance

    Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.

    Product
    CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide

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