FDA (Drugs) recall action 73960
The FDA (Drugs) publishes a recall like this one as 88 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 88 pages.
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.
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling 95 bags of compounded Fentanyl and Ropivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 175 units of compounded Ketamine 20 mg/mL due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 150 bags of compounded Fentanyl Citrate and Ropivacaine HCI injection due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 200 units of compounded Ketamine 50mg/mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 2,300 units of compounded Ondansetron 2mg/mL syringes because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 300 bags of Morphine Sulfate 1mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.
Pharmakon Pharmaceuticals is recalling 120 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 75 bags of Fentanyl Citrate injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 50 vials of Lidocaine 2% syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 2,580 units of compounded Propofol 1% injection because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 4,500 units of Hydromorphone 1mg/mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 150 units of compounded Ketamine 2 mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 20 units of compounded Hydromorphone HCI syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.