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High RiskFDA
Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system ...
Medical Devices·29 affected·Nov 17, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may...
Surgical Devices·4,890 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system...
Medical Devices·118 affected·Nov 17, 2017
High RiskFDA
Sichuan Youjia Foodstuffs Co., Ltd
BAMBOO SHOOTS SAUCE (Marinated Bamboo) packaged in a glass jar, net wt. 220g. UPC: 6 930841 008230
Food·40 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Almonds, Natural Dark Chocolate Almonds, 12/7 oz., and 12/12 oz.
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Natural Dark Chocolate Cranberries
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Coffee Beans, Natural Dark Chocolate Coffee Beans
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Almond Bark, 12/8oz.
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Jlm Manufacturing Llc
Dark Chocolate Raisins, Natural Dark Chocolate Raisins
Snacks & Candy·0 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca R...
Drugs·2,239 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Ra...
Topical Drugs·4,530 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton...
Topical Drugs·30 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Pa...
Oral Drugs·90 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Topical Drugs·300 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Drugs·129 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boc...
Drugs·1,203 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rat...
Topical Drugs·30 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Co...
Topical Drugs·300 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,...
Topical Drugs·3,280 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Injectable Drugs·696 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Supplements·3,612 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Oral Drugs·15,700 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Oral Drugs·970 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Drugs·122 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,...
Drugs·1,009 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only...
Ophthalmic Drugs·297 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, K...
Drugs·235 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Comm...
Topical Drugs·490 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commer...
Injectable Drugs·2,535 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Supplements·479 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce ...
Drugs·80 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Com...
Drugs·40 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Pa...
Drugs·100 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS...
Ophthalmic Drugs·81 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Topical Drugs·300 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Comme...
Injectable Drugs·963 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Oral Drugs·3,000 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Injectable Drugs·898 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park...
Drugs·80 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Ra...
Drugs·7,862 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Supplements·5,786 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Oral Drugs·90 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, ...
Drugs·597 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca R...
Drugs·6,414 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca...
Drugs·2,274 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Bo...
Oral Drugs·2,239 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only...
Drugs·94 affected·Nov 16, 2017
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Oral Drugs·3,000 affected·Nov 16, 2017