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KRS Global Biotechnology, Inc

FDA Regulatory Profile

Summary

Total Recalls
129
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0093-2020Class IISermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global BiotechnoSeptember 12, 2019
D-0102-2020Class IISodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx OnlSeptember 12, 2019
D-0059-2020Class IIHuman Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global BiotecSeptember 12, 2019
D-0051-2020Class IIfentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV September 12, 2019
D-0100-2020Class IISermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 79September 12, 2019
D-0042-2020Class IIBacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of CommercSeptember 12, 2019
D-0097-2020Class IISermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,September 12, 2019
D-0071-2020Class IILIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic InjectSeptember 12, 2019
D-0111-2020Class IIVitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 PSeptember 12, 2019
D-0041-2020Class IIAscorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, RxSeptember 12, 2019
D-0075-2020Class IIMoxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single DosSeptember 12, 2019
D-0096-2020Class IISermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global BiSeptember 12, 2019
D-0054-2020Class IIGLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global BiotechSeptember 12, 2019
D-0052-2020Class IIFluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global BiotechnSeptember 12, 2019
D-0046-2020Class IIePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, SSeptember 12, 2019
D-0039-2020Class IIAlpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS GlobaSeptember 12, 2019
D-0090-2020Class IIPolidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology September 12, 2019
D-0043-2020Class IIBimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global BSeptember 12, 2019
D-0053-2020Class IIGlutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS GlobaSeptember 12, 2019
D-0050-2020Class IIfentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IVSeptember 12, 2019