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.

11601–11625 of 29163

SevereFDA (Drugs)·D-1707-2019·2019-08-14
RXQ Compounding Recalls Sterile Water for Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Sterile Water for Injection USP vials because the product lacks assurance of sterility.
Product
STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 10 ML vial: 70731-0188-10; NDC 30 ML vial: 70731-0188-30; NDC 50 ML vial: 70731-0188-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2075-2019·2019-08-14
St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Product
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1692-2019·2019-08-14
RXQ Compounding Recalls Phenylephrine Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Phenylephrine HCL 100 mcg/mL syringes because the agency could not ensure the product was sterile.
Product
PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0136-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1717-2019·2019-08-14
RXQ Compounding Recalls Vitamin B Complex 100 Due to Sterility Concerns
RXQ Compounding LLC is recalling Vitamin B Complex 100 vials because the product may lack assurance of sterility.
Product
VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 2 ML Vial: 70731-0961-02; NDC 30 ML Vial: 70731-0961-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1663-2019·2019-08-14
RXQ Compounding Recalls Glutathione Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Glutathione 200mg/mL Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0906-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1653-2019·2019-08-14
RXQ Compounding Recalls EDETATE DISODIUM 15% INJECTABLE Due to Sterility Concerns
RXQ Compounding LLC is recalling EDETATE DISODIUM 15% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.
Product
EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0922-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2019·2019-08-14
Intellijoint G2 Workstation Recalled Due to MacBook Pro Fire Risk
Intellijoint Surgical is recalling 23 G2 Workstations because the Apple MacBook Pro components may overheat and pose a fire safety risk.
Product
Workstation, G2, Configured (P/N 000-0241)
Category
Medical Device
Distribution
5 states
SevereFDA (Drugs)·D-1687-2019·2019-08-14
RXQ Compounding Recalls Moxifloxacin Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Moxifloxacin 0.5% Ophthalmic Solution syringes because the product lacks assurance of sterility.
Product
MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0973-81
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1711-2019·2019-08-14
RXQ Compounding Recalls Travasol 10% Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Travasol 10% Injection Solution because the product lacks assurance of sterility.
Product
TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0151-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1719-2019·2019-08-14
RXQ Compounding Recalls Zinc Sulfate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Zinc Sulfate 1mg/mL Injection Solution because the product lacks assurance of sterility.
Product
ZINC SULFATE 1MG/ML INJECTION SOLUTION, 30ML per VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0152-30
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·19V598000·2019-08-14
E-One Fire Trucks Recalled for Front Shock Separation Risk
E-One is recalling specific Typhoon, Quest, and Cyclone II fire trucks because front shocks may separate, potentially damaging steering components and increasing crash risk.
Product
E-ONE — E-ONE QUEST, TYPHOON, CYCLONE II
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1655-2019·2019-08-14
RXQ Compounding Recalls Ephedrine Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Ephedrine 5mg/mL syringes nationwide because the product lacks assurance of sterility.
Product
EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0201-85
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1658-2019·2019-08-14
FDA Recalls Fentanyl Injection Due to Sterility Assurance Concerns
RXQ Compounding LLC is recalling fentanyl injection syringes because the agency could not ensure the product was sterile.
Product
fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0118-55
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1700-2019·2019-08-14
RXQ Compounding Recalls Pyridoxine Vials Due to Sterility Concerns
RXQ Compounding LLC is recalling Pyridoxine (PFV) 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0955-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2219-2019·2019-08-14
Ideal Implant Recalls Structured Saline Breast Implants Due to Deflation
Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.
Product
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1712-2019·2019-08-14
RXQ Compounding Recalls Turbo Caine 2.5 Due to Sterility Concerns
RXQ Compounding LLC is recalling Turbo Caine 2.5 syringes because the FDA determined there is a lack of assurance of sterility.
Product
TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0193-81
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1706-2019·2019-08-14
RXQ Compounding Recalls SOD-PHOS Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling SOD-PHOS injection vials because the product lacks assurance of sterility. The recall covers all lots within their expiry dates.
Product
SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0905-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2070-2019·2019-08-14
St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
Product
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1688-2019·2019-08-14
RXQ Compounding Recalls Neostigmine Methyl Sulfate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Neostigmine Methyl Sulfate 1mg/mL Injection Syringes due to a lack of assurance of sterility. The product was distributed nationwide.
Product
NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0143-05
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·19V597000·2019-08-14
Mitsubishi Fuso Trucks Recalled for Defective Rocker Arms
Mitsubishi Fuso is recalling 2017 FEC52, FEC72, FEC92, and FGB72 trucks because defective rocker arms may break, causing the engine to stall and increasing crash risk.
Product
MITSUBISHI FUSO — MITSUBISHI FUSO FGB72, FEC52, FEC72, FEC92
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1678-2019·2019-08-14
RXQ Compounding Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Methylcobalamin 1 mg/mL Injectable Solution because the product lacks assurance of sterility.
Product
METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0915-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1701-2019·2019-08-14
RXQ Compounding Recalls Riboflavin Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Riboflavin 0.1% Ophthalmic Solution syringes because the product lacks assurance of sterility.
Product
RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0923-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1709-2019·2019-08-14
RXQ Compounding Recalls Taurine Injectable Due to Sterility Concerns
RXQ Compounding LLC is recalling Taurine 50 mg/mL Injectable due to a lack of assurance of sterility. The product is distributed nationwide.
Product
TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0958-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1643-2019·2019-08-14
RXQ Compounding Recalls Copper Injection Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Copper 0.4MG/ML Injection Solution because the product lacks assurance of sterility.
Product
Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0925-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1713-2019·2019-08-14
RXQ Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product may not be sterile.
Product
TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0192-81
Category
Drug
Distribution
Distributed nationwide