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 Ondansetron 2 mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Inositol/Choline B12:B6 injection solution because there is a lack of 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 Sodium Bicarbonate 8.4% Injection due to a lack of assurance of sterility. The product is distributed nationwide.
RXQ Compounding LLC is recalling MIC (Methionine/Inositol/Choline Chloride) 25/50/50 mg/mL Injection due to a lack of assurance of sterility.
RXQ Compounding LLC is recalling Buffered Lidocaine 1%+Epi 1:100,000 Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling magnesium, calcium, and zinc vials due to a lack of assurance of sterility. The products were distributed nationwide.
RXQ Compounding LLC is recalling Dimercapto-Propanesulfonic 5% (DMPS) injection solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling ophthalmic solution vials due to a lack of assurance of sterility. The product is distributed nationwide.
RXQ Compounding LLC is recalling Dexpantenol 250mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Magnesium Chloride Hexahydrate 20% 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 Folic Acid 10mg/ml Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Ketamine 10 mg/mL Injection Solution due to a lack of assurance of sterility. The product was distributed nationwide.
RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the company cannot assure the product's sterility.
RXQ Compounding LLC is recalling Folic Acid 5mg/mL Injection Solution because the product lacks 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 Succinylcholine Chloride 20mg/mL injection 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 Ondansetron 2 mg/mL 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 vials because the product lacks assurance of sterility.
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 Vitamin B Complex 100 (MDV) vials because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Methylcobalamin 10 mg/mL injectable vials because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Ropivacaine 0.2% Injection Solution in On-Q Pumps because the product lacks assurance of sterility.