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 317 vials of Polidocanol 5% for IV use nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 3,820 syringes of Succinylcholine Chloride because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling 934 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 258 vials of Sermorelin Acetate and GHRP-2 because the product lacks assurance of sterility.
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 1,290 syringes of Moxifloxacin 0.1% ophthalmic injection nationwide due to a lack of assurance of sterility.
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.
KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.
KRS Global Biotechnology is recalling 2,625 syringes of Glycopyrrolate (PF) 1 mg/5 mL due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 2,219 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility. The product is distributed nationwide.
KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling L-Carnitine vials nationwide because the company cannot ensure the product is sterile.
KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.
KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Bimix #3 vials because the company cannot ensure the product is sterile.