FDA (Drugs) recall action 76912
The FDA (Drugs) publishes a recall like this one as 79 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 79 pages.
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to 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.
Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/4 injection vials because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid MDV Injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Cypionate injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injection because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 100mg/mL injections due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.