FDA (Drugs) recall action 65125
The FDA (Drugs) publishes a recall like this one as 25 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 25 pages.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
The agency’s own wording, quoted from the enforcement report.
The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling 43 vials of Sodium EDTA Injectable because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Methylcobalamin 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling Baclofen 500 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Phosphatidyl Choline 10% Injectable due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The FDA is recalling Procaine 1% Injectable vials due to quality control concerns regarding sterility assurance. The affected products were distributed in four states.
The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling MIC Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Tri-Mix Injections because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Avastin injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Praziquantel 56.8 mg vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Methotrexate 25mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Betamethasone 6 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Baclofen 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling Morphine Sulfate 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.