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 Ceftazidime ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling EDETATE DISODIUM ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Multitrace-4 pediatric injections because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin 10,000 mcg/mL injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution because sterility cannot be assured. The product was distributed to healthcare providers and patients in Michigan.
Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Potassium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Methocarbamol 100 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Fluorouracil PF 50 mg/mL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.
Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Cyclopentolate HCL ophthalmic products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Hyaluronidase products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Hydroxyprogesterone 17alpha-PF 250 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Sodium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.
Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.