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 specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.
Key Pharmacy and Compounding Center is recalling 214 vials of DMPS Acid injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Chloride Inhalation Solution because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot ensure 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 specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections due to a lack of assurance of sterility. The affected products were distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 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 specific lots of Procaine HCL 1% injections because the firm cannot assure the products are sterile.
Key Pharmacy and Compounding Center is recalling 25 vials of TRI MIX 20/20/1 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 specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.
Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, 40mcg/mL, 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 GSH/NAC Inhalation Solution 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 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 a specific lot of compounded ferric gluconate injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.
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 PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.