FDA (Drugs) recall action 64661
The FDA (Drugs) publishes a recall like this one as 49 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 49 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 unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Clinical Specialties Compounding Pharmacy is recalling Cyclosporine 2% ophthalmic due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test cyp 25 mg-Estadiol valerate 15 mg/mL due to lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling HCG 2000 units/ml syringes because FDA inspection findings raised concerns about quality control and assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Tetracaine 0.25% solution due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml due to FDA inspection findings regarding quality control and lack of sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Hydroxyprogesterone 250 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 10 mg/ml vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling 11ml vials of Test cyp 75 mg-estradiol cyp 5 mg/ml due to lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling HCG 1000 units/ml syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling a specific lot of Test cyp 25 mg-Estradiol cyp 5 mg/ml injection due to lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Itraconazole 1% eye ointment because FDA inspections raised concerns about quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling specific lots of Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test cyp 35 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin (modified) 0.02% solution because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 7 mg/ml due to lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling specific lots of Cyclosporine 1% ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 150 mg/ml injections because FDA inspections raised concerns about quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling specific lots of Progesterone 50 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling 120 ml injection vehicles due to FDA inspection findings regarding quality control and sterility assurance.