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 280 vials of compounded Epinephrine injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 90 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 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 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 Norepinephrine Bitartrate 4 mg in 5% Dextrose bags because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 40 units of compounded Promethazine injection due to a lack of assurance of sterility. The product was 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 Epinephrine HCI syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/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 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.
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 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Phenylephrine 40 mcg/mL injection syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products distributed nationwide and to specific VA/DOD facilities.
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 384 units of compounded Oxytocin in Lactated Ringers due to a lack of assurance of sterility.