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 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 216 units of Vancomycin HCL 1.25 GM in 5% Dextrose bags due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine 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 Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 1,809 units of compounded Oxytocin infusion bags nationwide due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 5% Dextrose 50 mL due to a lack of assurance of sterility. The recall affects 1,450 units distributed nationwide.
Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg in 0.9% sodium chloride due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 10 bags of Diltiazem HCI 250 mg in 5% Dextrose 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 1,200 units of Rocuronium 10mg/ml syringes because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 129 bags of Ropivacaine HCI 0.2% due to a lack of assurance of sterility. The product was 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 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 50 mcg/ml injections due to a lack of assurance of sterility. The recall affects 4,050 syringes distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 260 syringes of compounded fentanyl and bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL 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 Bupivacaine HCI 0.125% bags due to a lack of assurance of sterility. The recall affects 55 units distributed nationwide.
Pharmakon Pharmaceuticals is recalling 600 vials of compounded Ketamine 100mg/mL due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Pharmakon Pharmaceuticals is recalling 12 units of Hydromorphone HCl injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.