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 Phenylephrine-cyclopentolate due to FDA inspection findings regarding quality control and sterility.
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 Gentamicin buffered 36.4 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 30 mg/ml due to FDA inspection findings regarding quality control and 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 Test Cyp 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance. The product was distributed in Florida, Georgia, and South Carolina.
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 10% Solution 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 Test Cyp 50 mg-estradiol cyp 7 mg/ml due to lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml due to FDA inspection findings regarding quality control and lack of 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 Test Cyp 50 mg-estradiol blend 22 mg 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 Test cyp 25 mg-Estadiol valerate 15 mg/mL due to 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 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 100 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
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 specific lots of laser ophthalmic drops due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Methionine/Choline/Inositol/B-12 products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 50 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 2% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.