FDA (Drugs) recall action 66566
The FDA (Drugs) publishes a recall like this one as 51 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 51 pages.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
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.
Specialty Medicine Compounding Pharmacy is recalling Glycerin-Chromated 72% Injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Tropicamide 1% Ophthalmic Solution because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.
Specialty Medicine Compounding Pharmacy is recalling fluconazole and gentamicin solution because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.
Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.
Specialty Medicine Compounding Pharmacy is recalling Dexamethasone Sodium Phosphate solution because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling methylcobalamin injectable products because sterility cannot be assured after a related product was found to be non-sterile.
Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling cyanocobalamin injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.
Specialty Medicine Compounding Pharmacy is recalling Quad Mix injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling sodium tetradecyl sulfate injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Proparacaine HCl ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Papaverine HCL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.
Specialty Medicine Compounding Pharmacy is recalling Epinephrine products because sterility cannot be assured after a related product was found non-sterile.