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.
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 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 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 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 Methylcobalamin 5000 mcg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. 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 Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.
Red Mountain Compounding Pharmacy is recalling levocarnitine 100 mg/mL injectable solution (all lots within expiry) due to FDA inspection findings that raised sterility assurance concerns. Approximately 494 patients in seven states received prescriptions.
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 MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.
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 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.