The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20801–20825 of 32121

  • SevereFDA (Drugs)·D-0644-2016·2016-02-03

    Sentara Recalls Mycamine Micafungin Sodium Due to Sterility Concerns

    Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg because product sterility cannot be guaranteed.

    Product
    MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0639-2016·2016-02-03

    Sentara Recalls Clindamycin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0619-2016·2016-02-03

    Sentara Recalls Potassium Chloride Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS home infusion bags because sterility cannot be guaranteed.

    Product
    POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0623-2016·2016-02-03

    Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.

    Product
    VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0633-2016·2016-02-03

    Sentara Recalls Fluconzole Bags Due to Sterility Assurance Issues

    Sentara Enterprises is recalling 7 bags of Fluconzole in NaCl 400mg because product sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.

    Product
    FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0642-2016·2016-02-03

    Sentara Recalls Tobramycin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Tobramycin 120MG Homepumps because the sterility of the product cannot be guaranteed. The affected lots were compounded in September 2015.

    Product
    Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0631-2016·2016-02-03

    Sentara Recalls Morphine Infusion Bags Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Morphine 10mg/ml in NS infusion bags because the sterility of the product cannot be guaranteed.

    Product
    MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0629-2016·2016-02-03

    Sentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Cefepime Homepumps because the sterility of the product cannot be guaranteed.

    Product
    CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0624-2016·2016-02-03

    Sentara Recalls Ondansetron HCL 8mg Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling 77 bags of Ondansetron HCL 8mg Homepumps because the product's sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.

    Product
    ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·16090·2016-02-03

    Rockwood Multi-Function Power Packs Recalled Due to Fire Hazard

    Eastwood is recalling Rockwood power packs because their lithium-ion batteries can burst during charging, posing a fire hazard.

    Product
    Rockwood Multi-function power packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0640-2016·2016-02-03

    Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0641-2016·2016-02-03

    Sentara Recalls Gentamicin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Gentamicin Homepumps because the sterility of the product cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0627-2016·2016-02-03

    Sentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 7 syringes of Ascorbic Acid 500mg because the product's sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·16V063000·2016-02-03

    GM Recalls Saab and Saturn Vehicles for Air Bag Inflator Defect

    General Motors is recalling specific Saab and Saturn vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    SAAB — SAAB, SATURN 9-5, ASTRA, 9-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V060000·2016-02-03

    Subaru Recalls Tribeca Vehicles for Hood Safety System Malfunction

    Subaru is recalling 2006-2014 Tribeca vehicles because the hood may open unexpectedly while driving, potentially blocking the driver's view.

    Product
    SUBARU — SUBARU TRIBECA, B9 TRIBECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0622-2016·2016-02-03

    Sentara Recalls Dobutamine HCL Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling Dobutamine HCL in D5W home infusion bags because the sterility of the product cannot be guaranteed.

    Product
    DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0598-2016·2016-02-03

    Pharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.

    Product
    Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2016·2016-02-03

    Sentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS due to a lack of assurance of sterility. The affected product was distributed in Virginia and North Carolina.

    Product
    Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0618-2016·2016-02-03

    Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues

    Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0621-2016·2016-02-03

    Sentara Recalls Ceftriaxone Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Ceftriaxone in NS Homepumps because product sterility cannot be guaranteed. The recall affects 82 bags distributed in Virginia and North Carolina.

    Product
    CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·16V058000·2016-02-02

    Highland Ridge RV Recalls Travel Trailers With Underrated Safety Chains

    Highland Ridge RV is recalling 2015-2016 travel trailers because the safety chains are rated for less weight than the trailers' gross vehicle weight rating.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT, HIGHLAND RIDGE FW ROAMER, HIGHLANDER, MESA RIDGE, JOURNEYER
    Category
    Vehicle
    Distribution
    Distributed nationwide