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High RiskFDA
Deerfield Imaging, Inc.
IMRIS MR/X-ray head fixation device, Model HFD200
Medical Devices·3 affected·Jun 26, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is int...
Surgical Devices·2 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sys...
Surgical Devices·240 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·4 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sys...
Surgical Devices·350 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sy...
Surgical Devices·1 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·17 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is int...
Surgical Devices·4 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sys...
Surgical Devices·350 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is int...
Surgical Devices·2 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is ...
Surgical Devices·17 affected·Jun 25, 2019
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
Drugs·40 affected·Jun 24, 2019
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
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
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