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CriticalFDA
Fitoterapia Usa, Inc
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia...
Supplements·9,000 affected·Sep 16, 2019
CriticalFDA
Cme America, Llc
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infu...
Medical Devices·69,400 affected·Sep 16, 2019
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis...
Diagnostic Devices·740 affected·Sep 16, 2019
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis ...
Diagnostic Devices·740 affected·Sep 16, 2019
High RiskFDA
Icecure Medical Ltd
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extre...
Surgical Devices·16 affected·Sep 16, 2019
High RiskFDA
Becton Dickinson & Company
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Cat...
Surgical Devices·75 affected·Sep 16, 2019
RecallFDA
Productos La Samaritana, Inc.
La Samaritana Tortillas (Harina de Trigo) 8/12-12" Reg Rojo
Food·40 affected·Sep 13, 2019
High RiskFDA
Infinite Herbs, Llc
Conventional Basil with Basil Infinite Herbs & Specialties brand label. Basil was packed in 2.5 oz plastic clamshell, 4.0 oz. plastic cla...
Food·2 affected·Sep 13, 2019
High RiskFDA
Mowi Usa, Llc
MOWI brand. Whole, head-on gutted farmed, fresh Atlantic Salmon packed with ice inside Styrofoam coolers. Each cooler weighs approximatel...
Seafood·2,492 affected·Sep 13, 2019
RecallFDA
Productos La Samaritana, Inc.
Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate
Produce·138 affected·Sep 13, 2019
High RiskFDA
Abbott Laboratories
Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Baby Food & Formula·2,922 affected·Sep 13, 2019
RecallFDA
Guerbet Llc
Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, R...
Injectable Drugs·3,140 affected·Sep 13, 2019
High RiskFDA
Guerbet Llc
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power In...
Injectable Drugs·3,860 affected·Sep 13, 2019
High RiskFDA
Fortune International, Llc Dba Fortune Fish & Gourmet Llc
Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice
Seafood·2,004 affected·Sep 12, 2019
High RiskFDA
Star Fisheries, Inc.
Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh Irish Salmon Fillet Ireland Farmed. Random weight boxes fillets cut and dis...
Seafood·310 affected·Sep 12, 2019
CriticalFDA
Veritable Vegetable
Jayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate
Produce·363 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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, Boc...
Drugs·10,630 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 ...
Drugs·3,410 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial),...
Drugs·95 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, ...
Drugs·120 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Supplements·6,325 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL),...
Topical Drugs·242 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Co...
Drugs·6,447 affected·Sep 12, 2019
CriticalFDA
Shire Human Genetic Therapies, Inc.
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-...
Injectable Drugs·1,556 affected·Sep 12, 2019
CriticalFDA
Shire Human Genetic Therapies, Inc.
Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for:...
Injectable Drugs·8,003 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blv...
Drugs·7,685 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 P...
Drugs·602 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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...
Drugs·345 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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, ...
Injectable Drugs·0 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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...
Injectable Drugs·825 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Com...
Injectable Drugs·528 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 ...
Drugs·150 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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...
Injectable Drugs·540 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 332...
Injectable Drugs·6,568 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487...
Drugs·64 affected·Sep 12, 2019
RecallFDA
Pfizer Inc.
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfize...
Oral Drugs·7,686 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Commerc...
Drugs·6,405 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 o...
Drugs·4,105 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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, F...
Drugs·1,528 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Us...
Injectable Drugs·228 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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...
Injectable Drugs·317 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For ...
Drugs·497 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca...
Injectable Drugs·1,980 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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),...
Topical Drugs·649 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Bo...
Drugs·2,263 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Biotechnolo...
Injectable Drugs·492 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
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 Biotechno...
Injectable Drugs·928 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Bo...
Drugs·1,871 affected·Sep 12, 2019