FDA (Drugs) recall action 74187
The FDA (Drugs) publishes a recall like this one as 51 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 51 pages.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
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.
Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #4 because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.
Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product sterility.
Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Vitamin B Complex # 1 vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.
Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.
Well Care Compounding Pharmacy is recalling 869 units of Hydrogen Peroxide 3% due to FDA inspection findings regarding sterility assurance.
Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.
Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 100mg/mL due to FDA-identified GMP violations that may compromise sterility.
Well Care Compounding Pharmacy is recalling Vancomycin 50mg/mL ophthalmic solution due to FDA inspection findings of GMP violations that may impact sterility.
Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product sterility.
Well Care Compounding Pharmacy is recalling TRI-MIX # 3 vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling levocarnitine 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Methylcobalamin 5mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling M.l.C./B5/B6 injection vials due to FDA inspection findings of GMP violations that may impact sterility.
Well Care Compounding Pharmacy is recalling compounded L-Glutamine/L-Arginine/L-Carnitine injections due to FDA inspection findings regarding sterility assurance.
Well Care Compounding Pharmacy is recalling Myers' Cocktail vials due to FDA inspection findings of GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling QUAD-MIX #4 (MOD) vials because FDA inspections found violations that may affect product sterility.