FDA (Drugs) recall action 83789
The FDA (Drugs) publishes a recall like this one as 80 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 80 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.
KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.
KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is nationwide.
KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.
KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.
KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is nationwide.
KRS Global Biotechnology is recalling 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials because the product lacks assurance of sterility.
KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.
KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling ephedrine sulfate syringes nationwide because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.