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 Test Cypionate 100MG/ML in Ethyl Oleate Oil due to FDA inspection findings of sterility assurance concerns.
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 Ascorbic Acid (Non-Corn) 500mg/mL Solution for Injection due to lack of assured sterility identified during an FDA inspection. The affected product was distributed to approximately 494 patients in seven states.
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 pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple states received affected prescriptions.
Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.
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 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 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.
Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.
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 methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling methylcobalamin 10,000 MCG/ML multi-dose vials after FDA inspection identified sterility assurance concerns.