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 1GM syringes because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.
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 340 units of Morphine Sulfate syringes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD locations.
Pharmakon Pharmaceuticals is recalling 215 bags of Morphine Sulfate in Dextrose due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 130 bags of Bupivacaine 1mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 12 units of Adenosine 1mg/ml injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 72 bags of Magnesium Sulfate in Lactated Ringers due to a lack of assurance of sterility. The products were 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 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 4,500 units of Hydromorphone 1mg/mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 400 syringes of compounded Epinephrine due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.
Pharmakon Pharmaceuticals is recalling 200 units of Fentanyl Citrate injection due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and 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 650 syringes of Succinylcholine Chloride 20 mg/mL injection due to a lack of assurance of sterility.
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 40 units of Bupivacaine HCI 0.125% syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.
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 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI 40mg/250 mL bags because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 150 bags of compounded Fentanyl Citrate and Ropivacaine HCI injection due to a lack of assurance of sterility.