Skip to main content
High RiskFDA
Advanced Pharma Inc.
Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe...
Injectable Drugs·2,325 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella ...
Injectable Drugs·360 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, ND...
Injectable Drugs·22,900 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265...
Injectable Drugs·1,540 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe...
Injectable Drugs·1,440 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syring...
Injectable Drugs·1,575 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirb...
Injectable Drugs·550 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Hou...
Injectable Drugs·180 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby ...
Injectable Drugs·2,580 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella...
Injectable Drugs·1,850 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Ave...
Injectable Drugs·140 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 926...
Injectable Drugs·1,980 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use...
Injectable Drugs·800 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC:...
Injectable Drugs·1,125 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syr...
Injectable Drugs·16,075 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 428...
Injectable Drugs·500 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 4...
Injectable Drugs·2,400 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use s...
Injectable Drugs·975 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 A...
Injectable Drugs·5,700 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diame...
Medical Devices·7,248 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has application...
Medical Devices·240 affected·Mar 13, 2019
High RiskFDA
Medical Components, Inc Dba Medcomp
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Surgical Devices·6,830 affected·Mar 13, 2019
High RiskFDA
Medical Components, Inc Dba Medcomp
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing ...
Surgical Devices·6,830 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT0068...
Medical Devices·148 affected·Mar 13, 2019
High RiskFDA
Vanns Spices, Ltd
Casa de Sante, Asafetida Powder Organic, 2.6 oz. (74g) 6 per package
Food·250 affected·Mar 12, 2019
High RiskFDA
Nature Delivered Inc
Graze, Dark Chocolate Cherry Tart net weight / number of units per package: 1.6oz (44g), 1 unit per package, package type: plastic contai...
Snacks & Candy·19,800 affected·Mar 12, 2019
High RiskFDA
Akorn Inc
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. ...
Drugs·15,322 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufact...
Ophthalmic Drugs·200 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactu...
Ophthalmic Drugs·200 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology D...
Drugs·500 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027...
Ophthalmic Drugs·5,000 affected·Mar 12, 2019
High RiskFDA
Direct Rx
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking R...
Drugs·33 affected·Mar 12, 2019
High RiskFDA
Elekta Limited
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for rad...
Medical Devices·12 affected·Mar 12, 2019
High RiskFDA
Ethicon, Inc.
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in ped...
Medical Devices·550,681 affected·Mar 12, 2019
High RiskFDA
Philips North America, Llc
Azurion FlexArm, 722079
Medical Devices·2 affected·Mar 12, 2019
High RiskFDA
Iso-tex Diagnostics, Inc
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diag...
Injectable Drugs·54 affected·Mar 11, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is inte...
Diagnostic Devices·80 affected·Mar 11, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Cardiac Devices·11,420 affected·Mar 11, 2019
High RiskFDA
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Medical Devices·300 affected·Mar 11, 2019
High RiskFDA
Horizon Food Group
Ne-Mo's Birthday Cake Square with Buttercream Icing, item 506-6; Net Wt. 3 oz. Case UPC: 2007606405066 8 Display pk 6 ea/pk UPC: 10076...
Dairy·760 affected·Mar 10, 2019
High RiskFDA
Horizon Food Group
Ne-Mo's Red Velvet Cake Square with Cream Cheese Icing, item 408-6; Net Wt. 3 oz. Case UPC: 2007606404086 7 Display pk 6 ea/pk UPC: 10...
Dairy·2,428 affected·Mar 10, 2019
High RiskFDA
Horizon Food Group
Ne-Mo's Chocolate Cake Square with Cream Cheese Icing, item 104; Net Wt. 3 oz. Case UPC: 2007606401046 4; Display pk 6 ea/pk UPC: 1007...
Dairy·3,533 affected·Mar 10, 2019
High RiskFDA
Hometown Food Company
Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper bag retail. 8 bags per shrink wrapped bale wholesale. UPC "0 515002224...
Food·12,245 affected·Mar 8, 2019
High RiskFDA
Ardo N.v.
Trader Joe s Vegetable Melange In Seasoned Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0033 7038
Dairy·2,017 affected·Mar 8, 2019
High RiskFDA
Ardo N.v.
Trader Joe s Fire Roasted Vegetables With Balsamic Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0077 5175
Dairy·2,017 affected·Mar 8, 2019
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-6...
Oral Drugs·576 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Gyrus Acmi, Inc.
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Medical Devices·502 affected·Mar 8, 2019