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.

28201–28225 of 32252

  • SevereFDA (Drugs)·D-582-2013·2013-06-12

    Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.

    Product
    Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-541-2013·2013-06-12

    TG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1460-2013·2013-06-12

    Symbios Recalls GoPump and GoBlock Kits Due to Flow Rate Issues

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.

    Product
    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1458-2013·2013-06-12

    Symbios Medical Recalls GoPump and GoBlock Kits Due to Flow Control Defects

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to July 2012 due to reports of excessively high flow rates.

    Product
    Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1461-2013·2013-06-12

    Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.

    Product
    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-564-2013·2013-06-12

    B-Complex Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-543-2013·2013-06-12

    TG United Recalls Z-Dex Pediatric Drops Due to Dosage Deviations

    TG United, Inc. is recalling Z-Dex Pediatric Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1452-2013·2013-06-12

    Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates

    Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.

    Product
    Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V242000·2013-06-10

    Spartan Motor Homes Recalled for Front Wheel Bearing Fire Risk

    Spartan is recalling 2012-2013 K2, K3, and MM motor homes because incorrect front wheel bearings may cause the vehicle to pull and potentially start a fire.

    Product
    SPARTAN — SPARTAN K2, K3, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-495-2013·2013-06-05

    Nora Apothecary Recalls Pyridoxine Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Pyridoxine 100mg/ml Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-454-2013·2013-06-05

    Nora Apothecary Recalls Bimix Inj 30:0.5 MDV Penile Injection

    Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV Penile Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-481-2013·2013-06-05

    Nora Apothecary Recalls Hydroxycobalamin Injections Due to Sterility Concerns

    Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-461-2013·2013-06-05

    Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns

    Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-470-2013·2013-06-05

    Nora Apothecary Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Tobramycin Ophthalmic Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-457-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and the assurance of sterility.

    Product
    PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-477-2013·2013-06-05

    FDA Recalls HCG Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 1200un/ml MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-463-2013·2013-06-05

    Nora Apothecary Recalls Trimix Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-490-2013·2013-06-05

    Gentamicin Irrigation Recalled Due to Sterility Assurance Concerns

    Nora Apothecary is recalling Gentamicin 24mg/60ml Irrigation because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-492-2013·2013-06-05

    Nora Apothecary Recalls M.I.C.+B12 Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling M.I.C.+B12 Inj MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide