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 Cyanocobalamin 1200mcg/mL MDV Injection due to a lack of assurance of sterility. The product is distributed nationwide.
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 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 MIC B12 W/B6 (Lipostat Plus) vials because the FDA identified a lack of assurance of sterility.
RXQ Compounding LLC is recalling Procaine HCL 20 mg/mL Injectable Solution because the product lacks assurance of sterility.
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 Avastin 25mg/mL syringes because the company cannot ensure the product is sterile. The recall covers all lots within their expiration dates.
RXQ Compounding LLC is recalling Calcium Chloride 100mg/mL Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. The recall covers all lots within expiry 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 0.75%/Epinephrine 0.025% syringes because the FDA determined there is a lack of assurance of sterility.
RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling EDETATE DISODIUM 30% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Glutathione 200mg/ml Injection Solution because the product lacks assurance of sterility. All lots within expiry are affected nationwide.
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 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 Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE vials because the product lacks 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 Buffered Lidocaine HCL 1% Injection Solution because the product lacks assurance of sterility.
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 Thiamine HCL 100mg/mL Injection because the product lacks assurance of sterility. 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 Manganese Sulfate Monohydrate Injection because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Potassium Chloride 15% Injection Solution due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.