FDA (Drugs) recall action 83074
The FDA (Drugs) publishes a recall like this one as 86 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 86 pages.
Lack of Assurance of Sterility
Crystallization
The agency’s own wording, quoted from the enforcement report.
RXQ Compounding LLC is recalling Epinephrine 1:1000 Injection Solution syringes because the company cannot ensure the product is sterile.
RXQ Compounding LLC is recalling Molybdenum 0.025mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Epinephrine 4mg in D5W 5% infusion bags because the agency could not ensure the product was sterile.
RXQ Compounding LLC is recalling Zinc Sulfate 1mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Sterile Water for Injection USP vials because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Phenylephrine HCL 100 mcg/mL syringes because the agency could not ensure the product was sterile.
RXQ Compounding LLC is recalling Vitamin B Complex 100 vials because the product may lack assurance of sterility.
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.
RXQ Compounding LLC is recalling Fentanyl and Bupivacaine syringes nationwide due to a lack of assurance of sterility.
RXQ Compounding LLC is recalling EDETATE DISODIUM 15% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling hydromorphone syringes because the company cannot ensure the product is sterile.
RXQ Compounding LLC is recalling Moxifloxacin 0.5% Ophthalmic Solution syringes because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Travasol 10% Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Zinc Sulfate 1mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Ephedrine 5mg/mL syringes nationwide because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling fentanyl injection syringes because the agency could not ensure the product was sterile.
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.
RXQ Compounding LLC is recalling Turbo Caine 2.5 syringes because the FDA determined there is a lack of assurance of sterility.
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.
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.
RXQ Compounding LLC is recalling Methylcobalamin 1 mg/mL Injectable Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Riboflavin 0.1% Ophthalmic Solution syringes because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Taurine 50 mg/mL Injectable due to a lack of assurance of sterility. The product is distributed nationwide.
RXQ Compounding LLC is recalling Copper 0.4MG/ML Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product may not be sterile.