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-Methylcobalamin injections due to a lack of assurance of sterility. The recall covers 60 vials distributed nationwide.
Red Mountain Compounding Pharmacy is recalling S-Edetate Calcium 300mg/mL injection vials because the FDA identified a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Cypionate 100mg/mL in sesame oil due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Calm Injection vials because the FDA identified a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling 81 vials of S-Ascorbic Acid 500mg/mL due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Glutathione 200mg/mL vials due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Atropine 0.01% Ophthalmic Solution because the agency could not ensure the product was sterile.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Edetate Disodium 15% Injection because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% Injection because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Folic Acid 10mg/ml injection vials due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of zinc sulfate solution because the FDA could not ensure the product was sterile.
Red Mountain Compounding Pharmacy is recalling S-Testosterone Ultra 250mg/ml vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-DMPS 50mg/ml injection vials because the FDA identified a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific vials of Magnesium Sulfate Injection because the FDA determined there is a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/NAN-DECA 200/50MG/ML MDV in sesame oil because the agency could not ensure the product was sterile.
Red Mountain Compounding Pharmacy is recalling specific lots of lidocaine and phenylephrine injection syringes due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection vials due to a lack of assurance of sterility. The product was distributed nationwide in the USA.
Red Mountain Compounding Pharmacy is recalling specific lots of 3% hydrogen peroxide vials due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the FDA determined there is a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 40mg/mL injection vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Test Cyp 25mg/ml in sesame oil due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Gentamicin 480mg/1L irrigation solution because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of Vitamin D3 10,000 IU/mL oil injection due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-DMSO 100% sterile solution vials due to a lack of assurance of sterility.