FDA (Drugs) recall action 83669
The FDA (Drugs) publishes a recall like this one as 100 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 100 pages.
Lack of Assurance of 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.
Red Mountain Compounding Pharmacy is recalling S-Dextrose 50% vials because the FDA cannot ensure the product is sterile.
Red Mountain Compounding Pharmacy is recalling specific lots of S-DMSO 6.25% ophthalmic solution because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-HCG/B12A injection vials due to a lack of assurance of sterility. The recall affects 11 vials distributed nationwide.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Folic Acid 20mg/mL injection because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Calcium Gluconate 10% Injection due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Cypionate 200mg/mL vials because the FDA identified a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-B5/B6/B12M solution vials because the FDA cannot ensure the product is sterile.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Taurine 50mg/ml vials because the FDA determined there is a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Calcium Glucunate 1% Opth Irrigation due to a lack of assurance of sterility. The product was distributed nationwide.
Red Mountain Compounding Pharmacy is recalling S-Hydroxyprogesterone Caproate injections due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP 100mg/ml vials because the FDA identified a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-SOD Citrate 4% Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.
Red Mountain Compounding Pharmacy is recalling S-TEST CYP 25mg/ml vials nationwide due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of Calcium Chloride Injection because the product may not be sterile.
Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin 25mg/mL injections because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Hydrochloric Acid Injection due to a lack of assurance of sterility. The affected products were distributed nationwide.
Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 20mg/mL injection vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50MG/ML MDV SOLN vials nationwide due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-E2/Test Cyp 1mg/4mg sesame oil injections due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml vials because the FDA determined there is a lack of assurance of sterility.
First Royal Care Co. LLC is recalling S-TRIMIX compounded injections nationwide due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Dextrose/Glycerin/Phenol injection vials due to a lack of assurance of sterility. The product was distributed nationwide.
Red Mountain Compounding Pharmacy is recalling S-TEST CYP 125mg/ml vials due to a lack of assurance of sterility.