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.

11551–11575 of 29163

  • SevereFDA (Drugs)·D-1703-2019·2019-08-14

    RXQ Compounding Recalls Phenylephrine and Lidocaine Ophthalmic Solution

    RXQ Compounding LLC is recalling ophthalmic solution vials due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0918-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1645-2019·2019-08-14

    RXQ Compounding Recalls Dexpantenol Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Dexpantenol 250mg/mL Injection Solution because the product lacks assurance of sterility.

    Product
    DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0932-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1675-2019·2019-08-14

    RXQ Compounding Recalls Magnesium Chloride Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Magnesium Chloride Hexahydrate 20% Injection Solution because the product lacks assurance of sterility.

    Product
    MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0951-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1686-2019·2019-08-14

    RXQ Compounding Recalls Morphine Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Morphine 1mg/mL in NaCl 0.9% 55mL syringes because the company cannot ensure the product is sterile.

    Product
    MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0138-89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1660-2019·2019-08-14

    RXQ Compounding Recalls Folic Acid Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Folic Acid 10mg/ml Injection Solution because the product lacks assurance of sterility.

    Product
    FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0921-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1670-2019·2019-08-14

    RXQ Compounding Recalls Ketamine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ketamine 10 mg/mL Injection Solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC: 70731-0132-05] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1683-2019·2019-08-14

    RXQ Compounding Recalls Midazolam Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the company cannot assure the product's sterility.

    Product
    MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1661-2019·2019-08-14

    RXQ Compounding Recalls Folic Acid Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Folic Acid 5mg/mL Injection Solution because the product lacks assurance of sterility.

    Product
    FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0924-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1671-2019·2019-08-14

    RXQ Compounding Recalls Lidocaine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Lidocaine HCL 1% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0174-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1708-2019·2019-08-14

    RXQ Compounding Recalls Succinylcholine Chloride Injections Due to Sterility Concerns

    RXQ Compounding LLC is recalling Succinylcholine Chloride 20mg/mL injection vials because the product lacks assurance of sterility.

    Product
    SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0129-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1697-2019·2019-08-14

    RXQ Compounding Recalls Procaine HCL Injectable Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Procaine HCL 20 mg/mL Injectable Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0900-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1690-2019·2019-08-14

    RXQ Compounding Recalls Ondansetron Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ondansetron 2 mg/mL Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0157-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1652-2019·2019-08-14

    RXQ Compounding Recalls EDETATE DISODIUM 15% INJECTABLE Due to Sterility Concerns

    RXQ Compounding LLC is recalling EDETATE DISODIUM 15% INJECTABLE vials because the product lacks assurance of sterility.

    Product
    EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0922-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1634-2019·2019-08-14

    RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

    RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.

    Product
    Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1716-2019·2019-08-14

    RXQ Compounding Recalls Vitamin B Complex 100 Due to Sterility Concerns

    RXQ Compounding LLC is recalling Vitamin B Complex 100 (MDV) vials because the product lacks assurance of sterility.

    Product
    VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0976-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1679-2019·2019-08-14

    RXQ Compounding Recalls Methylcobalamin Injectable Due to Sterility Concerns

    RXQ Compounding LLC is recalling Methylcobalamin 10 mg/mL injectable vials because the product lacks assurance of sterility.

    Product
    METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0902-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2072-2019·2019-08-14

    St Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures

    St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1702-2019·2019-08-14

    RXQ Compounding Recalls Ropivacaine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ropivacaine 0.2% Injection Solution in On-Q Pumps because the product lacks assurance of sterility.

    Product
    ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0238-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2019·2019-08-14

    RXQ Compounding Recalls Cyanocobalamin Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Cyanocobalamin 1200mcg/mL MDV Injection due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0946-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1684-2019·2019-08-14

    RXQ Compounding Recalls Mitomycin Ophthalmic Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Mitomycin 0.04% ophthalmic solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0917-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1715-2019·2019-08-14

    RXQ Compounding Recalls Turbo Drops Ophthalmic Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0205-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1681-2019·2019-08-14

    RXQ Compounding Recalls MIC B12 W/B6 Due to Sterility Concerns

    RXQ Compounding LLC is recalling MIC B12 W/B6 (Lipostat Plus) vials because the FDA identified a lack of assurance of sterility.

    Product
    MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0978-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1696-2019·2019-08-14

    RXQ Compounding Recalls Procaine HCL Injectable Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Procaine HCL 20 mg/mL Injectable Solution because the product lacks assurance of sterility.

    Product
    PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0987-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1677-2019·2019-08-14

    RXQ Compounding Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Methylcobalamin 10mg/ml Injectable Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0130-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1637-2019·2019-08-14

    RXQ Compounding Recalls Avastin Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Avastin 25mg/mL syringes because the company cannot ensure the product is sterile. The recall covers all lots within their expiration dates.

    Product
    Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-0197-92; c) 0.15 mL NDC 70731-0197-93] per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
    Category
    Drug
    Distribution
    Distributed nationwide