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 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 Travasol 10% Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Buffered Lidocaine HCL 1% Injection Solution due to a lack of 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 Dimercapto-Propanesulfonic 5% (DMPS) injection solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Morphine 1mg/mL in NaCl 0.9% 55mL syringes because the company cannot ensure the product is 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 Magnesium Chloride Hexahydrate 20% Injection Solution because the product lacks assurance of sterility.
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.
RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling diazePAM 5 MG/ML 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 Prednisolone 1% and Moxifloxacin 0.5% ophthalmic solution due to a lack of assurance of sterility.
RXQ Compounding LLC is recalling EDETATE DISODIUM 15% INJECTABLE vials because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Dexpantenol 250mg/mL Injection Solution 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 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 Moxifloxacin 0.5% Ophthalmic Solution syringes because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Sodium Bicarbonate 8.4% Injection due to a lack of assurance of sterility. The product is distributed nationwide.
RXQ Compounding LLC is recalling Pyridoxine (MDV) 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Lidocaine HCL 2% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within their expiry dates.
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 Hydrogen Peroxide 3% Injectable PFV because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Procaine HCL 8% Injectable due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.