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 650 syringes of Succinylcholine Chloride 20 mg/mL injection due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 468 units of compounded Oxytocin 30 Units in Lactated Ringers due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 670 vials of compounded Hydromorphone HCl 0.4mg/ml due to a lack of assurance of sterility. The products were distributed nationwide to VA and 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 Phenylephrine HCI 40mg/250 mL bags because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling Cefazolin 1GM syringes because the company cannot ensure the product is sterile.
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 20 bags of compounded Fentanyl Citrate and Ropivacaine HCI due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 70 bags of Norepinephrine Bitartrate 8mg in 5% Dextrose due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.