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High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pi...
Medical Devices·42 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·169 affected·Aug 21, 2018
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Medical Devices·2 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as ...
Medical Devices·3 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Medical Devices·106 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·10 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·106 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated f...
Medical Devices·241 affected·Aug 21, 2018
High RiskFDA
Ochoa's Queseria Llc
Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Cheese***Ingredients: Pasteurized Whey, Salt***" 1lb....
Dairy·1,357 affected·Aug 20, 2018
High RiskFDA
Hetero Labs Limited Unit V
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob N...
Oral Drugs·98,016 affected·Aug 20, 2018
High RiskFDA
Remedyrepack Inc.
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38...
Oral Drugs·3 affected·Aug 20, 2018
High RiskFDA
Varian Medical Systems
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision ra...
Medical Devices·4 affected·Aug 20, 2018
High RiskFDA
Nordicneurolab As
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and present...
Medical Devices·163 affected·Aug 20, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a sin...
Surgical Devices·2,361 affected·Aug 20, 2018
High RiskFDA
Air Stream Corp.
Shredded green cabbage
Food·887 affected·Aug 18, 2018
High RiskFDA
Portland Chocolate Company Llc
60% Dark Chocolate Chips, packaged in poly-lined cardboard boxes, net wt. 30 lbs. The label is read in parts: "*** Pitch Dark Chocola...
Dairy·3,450 affected·Aug 18, 2018
High RiskFDA
Air Stream Corp.
Green Kale
Food·887 affected·Aug 18, 2018
High RiskFDA
Air Stream Corp.
Brussel Sprouts
Food·887 affected·Aug 18, 2018
High RiskFDA
Air Stream Corp.
Radicchio, 10 lbs
Food·887 affected·Aug 18, 2018
High RiskFDA
Reser's Fine Foods, Inc.
Three Cheese Pasta Spinache Stonemill Kitchens, item # 71117.19500, 2/5 # packages. UPC 0 71117 19500 2. Product is pasta salads wit...
Dairy·423 affected·Aug 17, 2018
High RiskFDA
Reser's Fine Foods, Inc.
Bow Tie Pasta Caesar Molly's Kitchen, item # 58108.76434, Inner Containter Item # 58108.30168, 2/4.5 # packages per case. UPC 0 58108 3...
Produce·121 affected·Aug 17, 2018
High RiskFDA
Reser's Fine Foods, Inc.
Bow Tie Florentine Reser's Fine Foods, item # 71117.15314, 2/4.5 # packages. UPC 0 71117 15314 9. Product is pasta salads with vin...
Produce·315 affected·Aug 17, 2018
High RiskFDA
Tipu's Chai
Tipu's Chai - Sweetened Masala Chai, Net wt.7.5 oz. per box. UPC #: 7 19196 20035 3. Each box contains five single serve sachet packets ...
Dairy·60 affected·Aug 17, 2018
High RiskFDA
Blommer Chocolate Co., Inc.
Blommer Natural Cocoa Butter Bulk Tanker
Dairy·95,040 affected·Aug 17, 2018
High RiskFDA
Church & Dwight Co
Trader Darwin s Chewable Peppermint Flavored Melatonin Dietary Supplement Number of units per package: 100 tablets Package type: Bottle ...
Supplements·98,604 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indra...
Oral Drugs·66,864 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent ...
Oral Drugs·37,704 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indr...
Oral Drugs·89,616 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: ...
Oral Drugs·14,016 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torre...
Oral Drugs·50,784 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indra...
Oral Drugs·78,144 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: ...
Oral Drugs·0 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: ...
Oral Drugs·24,468 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent...
Oral Drugs·169,200 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indra...
Oral Drugs·46,272 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent...
Oral Drugs·34,320 affected·Aug 17, 2018
High RiskFDA
Torrent Pharma Inc.
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torre...
Oral Drugs·22,704 affected·Aug 17, 2018
High RiskFDA
Pacific Coast Fruit Company
Spinach Chopped 1", item # 73039. packaged in plastic bag, each case contains 2/5# bags, There are case labels and no unit label. UPC o...
Produce·126 affected·Aug 16, 2018
High RiskFDA
Sammy Food Products Llc
Sammy Salsa Happy Medium, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000110. The label is read in parts: "...
Produce·60 affected·Aug 15, 2018
High RiskFDA
Sammy Food Products Llc
Sammy Salsa Roasted Cabo Verde, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000141. The label is read in par...
Beverages·10 affected·Aug 15, 2018
High RiskFDA
Sammy Food Products Llc
Sammy Salsa Smok'n Chipotle, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000134. The label is read in parts:...
Snacks & Candy·17 affected·Aug 15, 2018
High RiskFDA
Sammy Food Products Llc
Sammy Salsa Pleasantly Mild, packaged in 14 oz. plastic container, 6 units per case. UPC 00868422000127. The label is read in parts: ...
Produce·36 affected·Aug 15, 2018
High RiskFDA
Preferred Pharmaceuticals, Inc
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., ...
Oral Drugs·9 affected·Aug 15, 2018
High RiskFDA
Agfa N.v.
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics ...
Medical Devices·108 affected·Aug 15, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, s...
Cardiac Devices·23,064 affected·Aug 15, 2018
High RiskFDA
Avkare Inc.
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Oral Drugs·6,776 affected·Aug 14, 2018
High RiskFDA
Avkare Inc.
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Oral Drugs·818 affected·Aug 14, 2018
High RiskFDA
Avkare Inc.
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Oral Drugs·1,496 affected·Aug 14, 2018