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 Ropivacaine 0.2% Injection Solution in On-Q Pumps because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Niacinamide 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
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 injection syringes because the agency could not ensure the product was sterile.
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.
RXQ Compounding LLC is recalling Folic Acid 10mg/ml Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the company cannot assure the product's sterility.
RXQ Compounding LLC is recalling Edetate Disodium 150mg/mL PFV vials because the product lacks assurance of sterility.
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.
RXQ Compounding LLC is recalling Riboflavin 0.1% Ophthalmic Solution syringes because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling PHO-TID-CHOL 50MG/DEOXYCHOLIC 42 MG/ML Injection due to a lack of 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 voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Cyanocobalamin 1200mcg/mL MDV Injection 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 Vitamin B Complex 100 vials because the product may lack assurance of sterility.
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.
RXQ Compounding LLC is recalling EDETATE DISODIUM 15% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Calcium Glucunate 5% Injection Solution because the FDA determined there is a lack of assurance of sterility.
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product may not be sterile.
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.
RXQ Compounding LLC is recalling MIC B12 W/B6 (Lipostat Plus) vials because the FDA identified a lack of assurance of sterility.
RXQ Compounding LLC is recalling Ondansetron 2 mg/mL Injection Solution because the product lacks assurance of sterility.