KRS Global Biotechnology, Inc

FDA Drug Class II Terminated

GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316

September 12, 2019 KRS Global Biotechnology, Inc 10630 syringes units

FDA Drug Class II Terminated

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303

September 12, 2019 KRS Global Biotechnology, Inc 3410 syringes units

FDA Drug Class II Terminated

Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B

September 12, 2019 KRS Global Biotechnology, Inc 95 vials units

FDA Drug Class II Terminated

Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092

September 12, 2019 KRS Global Biotechnology, Inc 120 vials units

FDA Drug Class II Terminated

Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339

September 12, 2019 KRS Global Biotechnology, Inc 6325 vials units

FDA Drug Class II Terminated

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Dropt

September 12, 2019 KRS Global Biotechnology, Inc 242 droptainers units

FDA Drug Class II Terminated

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

September 12, 2019 KRS Global Biotechnology, Inc 6447 vials units

FDA Drug Class II Terminated

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847

September 12, 2019 KRS Global Biotechnology, Inc 7685 syringes units

FDA Drug Class II Terminated

Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033

September 12, 2019 KRS Global Biotechnology, Inc 602 vials units

FDA Drug Class II Terminated

Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334

September 12, 2019 KRS Global Biotechnology, Inc 345 vials units

FDA Drug Class II Terminated

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032

September 12, 2019 KRS Global Biotechnology, Inc 528 bags units

FDA Drug Class II Terminated

Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton,

September 12, 2019 KRS Global Biotechnology, Inc N/A units

FDA Drug Class II Terminated

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Rato

September 12, 2019 KRS Global Biotechnology, Inc 825 syringe units

FDA Drug Class II Terminated

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603

September 12, 2019 KRS Global Biotechnology, Inc 150 vials units

FDA Drug Class II Terminated

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca

September 12, 2019 KRS Global Biotechnology, Inc 540 syringes units

FDA Drug Class II Terminated

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177

September 12, 2019 KRS Global Biotechnology, Inc 6568 vials units

FDA Drug Class II Terminated

Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122

September 12, 2019 KRS Global Biotechnology, Inc 64 vials units

FDA Drug Class II Terminated

Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419

September 12, 2019 KRS Global Biotechnology, Inc 6405 syringes units

FDA Drug Class II Terminated

LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca R

September 12, 2019 KRS Global Biotechnology, Inc 4105 syringes units

FDA Drug Class II Terminated

Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336

September 12, 2019 KRS Global Biotechnology, Inc 1528 units

FDA Drug Class II Terminated

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,

September 12, 2019 KRS Global Biotechnology, Inc 228 bags units

FDA Drug Class II Terminated

Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749

September 12, 2019 KRS Global Biotechnology, Inc 317 vials units

FDA Drug Class II Terminated

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce

September 12, 2019 KRS Global Biotechnology, Inc 497 vials units

FDA Drug Class II Terminated

Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632

September 12, 2019 KRS Global Biotechnology, Inc 1980 vials units

FDA Drug Class II Terminated

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only,

September 12, 2019 KRS Global Biotechnology, Inc 649 droptainers units

FDA Drug Class II Terminated

Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969

September 12, 2019 KRS Global Biotechnology, Inc 2263 vials units

FDA Drug Class II Terminated

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321628

September 12, 2019 KRS Global Biotechnology, Inc 492 bags units

FDA Drug Class II Terminated

Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216

September 12, 2019 KRS Global Biotechnology, Inc 928 vials units

FDA Drug Class II Terminated

Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977

September 12, 2019 KRS Global Biotechnology, Inc 1871 vials units

FDA Drug Class II Terminated

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

September 12, 2019 KRS Global Biotechnology, Inc 948 vials units

FDA Drug Class II Terminated

NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343

January 16, 2019 KRS Global Biotechnology, Inc 190 250 mL bags units

FDA Drug Class II Terminated

NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481

January 16, 2019 KRS Global Biotechnology, Inc 433 250 mL bags units

FDA Drug Class II Terminated

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 90 capsules units

FDA Drug Class II Terminated

Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 300 jars units

FDA Drug Class II Terminated

QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 129 vials units

FDA Drug Class II Terminated

Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 1,203 vials units

FDA Drug Class II Terminated

Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 30 jars units

FDA Drug Class II Terminated

Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 300 jars units

FDA Drug Class II Terminated

Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 3,280 jars units

FDA Drug Class II Terminated

Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 696 vials units

FDA Drug Class II Terminated

Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 3612 vials units

FDA Drug Class II Terminated

Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 15,700 capsules units

FDA Drug Class II Terminated

Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 970 capsules units

FDA Drug Class II Terminated

QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 122 vials units

FDA Drug Class II Terminated

Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 1,009 vials units

FDA Drug Class II Terminated

Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rat

November 16, 2017 KRS Global Biotechnology, Inc 297 droptainers units

FDA Drug Class II Terminated

Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,

November 16, 2017 KRS Global Biotechnology, Inc 235 vials units

FDA Drug Class II Terminated

Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 490 jars units

FDA Drug Class II Terminated

Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 2,535 vials units

FDA Drug Class II Terminated

Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

November 16, 2017 KRS Global Biotechnology, Inc 479 vials units