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High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Drugs·12 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Medical Devices·116 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
NOSEBLEED TRAY Kit Code: MNS3885
Medical Devices·30 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Model # 728231, computed tomography x-ray system
Medical Devices·582 affected·Jun 24, 2019
CriticalFDA
Fenwal Inc
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Softw...
Medical Devices·83 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
EPISTAXIS TRAY Kit Code: MNS10165
Medical Devices·525 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
iCT, Model # 728306, computed tomography x-ray system
Medical Devices·128 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT, Model # 728326, computed tomography x-ray system
Medical Devices·92 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
YNHH SCOPE KIT Kit Code: MNS10475
Medical Devices·644 affected·Jun 24, 2019
CriticalFDA
Fenwal Inc
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of t...
Medical Devices·9,461 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Origen Biomedical, Inc.
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Medical Devices·6 affected·Jun 24, 2019
High RiskFDA
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy t...
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Pharma-natural Inc.
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl o...
Drugs·3,000 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distrib...
Topical Drugs·1,000 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Di...
Drugs·500 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Cros...
Topical Drugs·1,508 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, U...
Topical Drugs·19,422 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by:...
Oral Drugs·5,273 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. ...
Drugs·7,392 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply o...
Topical Drugs·2,000 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distribute...
Topical Drugs·1,000 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharm...
Topical Drugs·310 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) b...
Drugs·8,340 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., ...
Topical Drugs·1,070 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 ...
Drugs·2,052 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Mia...
Topical Drugs·1,032 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by...
Topical Drugs·998 affected·Jun 21, 2019
High RiskFDA
Pharma-natural Inc.
ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover...
Drugs·4,981 affected·Jun 21, 2019
High RiskFDA
Tropical Nut & Fruit Company
Truly Good Foods Edamame Beans Roasted and Salted 7 oz. (198g) plastic clam shell DISTRIBUTED BY TRULY GOOD FOODS, CHARLOTTE, NC 28273 UP...
Food·989 affected·Jun 20, 2019
High RiskFDA
Perrigo Company Plc
Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468
Dairy·23,388 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufacture...
Oral Drugs·4,277 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsb...
Oral Drugs·142,626 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured b...
Oral Drugs·47,520 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plains...
Oral Drugs·29,106 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plain...
Oral Drugs·145,162 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·47 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·21 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Cardiac Devices·15 affected·Jun 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios care fusion system
Medical Devices·1 affected·Jun 20, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Norm-O-Temp model 111Z
Medical Devices·674 affected·Jun 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha VA20/ VA30 mobile X-Ray systems
Medical Devices·1 affected·Jun 20, 2019
High RiskFDA
Unfi General Corporate
WOODSTOCK ORGANIC GRILLED RED PEPPER, NET WT 10. OZ, packaged in a plastic packaged marked with UPC Code: 4256301714. Frozen.
Frozen Food·1,010 affected·Jun 19, 2019
High RiskFDA
Rxq Compounding Llc
GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0...
Injectable Drugs·0 affected·Jun 19, 2019
High RiskFDA
Rxq Compounding Llc
VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0976-30
Supplements·0 affected·Jun 19, 2019
High RiskFDA
Rxq Compounding Llc
MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 7073...
Drugs·0 affected·Jun 19, 2019
High RiskFDA
Rxq Compounding Llc
TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731...
Injectable Drugs·0 affected·Jun 19, 2019
High RiskFDA
Rxq Compounding Llc
BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC...
Injectable Drugs·0 affected·Jun 19, 2019