KRS Global Biotechnology, Inc

FDA Regulatory Profile

KRS Global Biotechnology, Inc appears in FDA public data with 129 recalls, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0096-2020, Class II) was initiated on September 12, 2019.

Summary

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

Recent Recalls

NumberClassProductDate
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-0113-2020Class IIVitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,September 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-0111-2020Class IIVitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 PSeptember 12, 2019
D-0098-2020Class IISermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park oSeptember 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-0118-2020Class IIIsoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains September 12, 2019
D-0110-2020Class IIVitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce 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-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-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-0063-2020Class IIHydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 September 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-0095-2020Class IISermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global BioSeptember 12, 2019
D-0114-2020Class IIVitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce BlSeptember 12, 2019
D-0069-2020Class IILIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS GSeptember 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-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-0072-2020Class IIMethionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / CyanocSeptember 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