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 Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.
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 TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Vitamin D3 in Olive Oil SDV 100,000U/mL Injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.
Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling TRI MIX 5/30/0.5 injection vials because the firm cannot ensure the sterile compounded drugs are free from contamination.
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 a specific lot of TRI MIX injection 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 specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injection because the firm cannot ensure the sterile compounded drugs are free from contamination.
Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the products.
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 compounded progesterone injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling 72 vials of HCG injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Vitamin D3 in Olive Oil Injection due to a lack of assurance of sterility.
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 specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.
Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a lack of assurance of sterility.