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 EDETATE DISODIUM 30% INJECTABLE, 100 ML vials, because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Buffered Lidocaine HCL 1% Injection Solution 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 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 Potassium Chloride 15% Injection Solution due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.
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 Succinylcholine Chloride 20mg/mL injection vials 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 Epinephrine 4mg in D5W 5% infusion bags because the agency could not ensure the product was sterile.
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 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 Magnesium Chloride Hexahydrate 20% Injection Solution because the product lacks assurance of sterility.
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 Buffered Lidocaine 1%+Epi 1:100,000 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 Zinc Sulfate 1mg/mL Injection Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Vitamin B Complex 100 (MDV) vials 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 hydromorphone syringes because the company cannot ensure the product is sterile.
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 EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE vials because the product lacks assurance of sterility.
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 Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. 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 Molybdenum 0.025mg/mL Injection Solution because the product lacks assurance of sterility.