FDA (Drugs) recall action 88693
The FDA (Drugs) publishes a recall like this one as 40 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 40 pages.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
The agency’s own wording, quoted from the enforcement report.
First Royal Care Compounding Pharmacy is recalling Test Cyp 50mg/ml in ethyl oleate oil due to FDA inspection findings that raised concerns about sterility assurance. About 494 patients in seven states received prescriptions for the affected product.
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.
Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 2% Ophthalmic Solution due to lack of assurance of sterility. The FDA identified concerns during an inspection of the manufacturing facility.
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injectable Solution (HP) due to lack of assurance of sterility raised during FDA inspection. Approximately 494 patients across seven states received affected prescriptions.
Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.
Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.
Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.
Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.
First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Calcium Chloride 100 mg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.
Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.
Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.
Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.
Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.
Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.
Red Mountain Compounding Pharmacy is recalling folic acid injectable medication because the FDA found the product lacks adequate sterility assurance. The recall affects prescriptions distributed across multiple states.
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.