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High RiskFDA
Gemini Food Corporation Inc
Imperial Taste Fried Garlic, Tu Phi; 24 x 8oz. Item #1763 UPC Code: 741861017638; 24 x 12oz. Item #1762 UPC Code: 741861017621 Ing...
Food·715 affected·Nov 27, 2018
High RiskFDA
Gemini Food Corporation Inc
Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 741861017607; 24 x 12oz. Item #1761, UPC Code: 74186101...
Produce·581 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Man...
Oral Drugs·120,394 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Man...
Oral Drugs·75,883 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Ma...
Oral Drugs·142,260 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (N...
Oral Drugs·31,079 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Ma...
Oral Drugs·39,617 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (...
Oral Drugs·19,458 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (N...
Oral Drugs·37,957 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles ...
Oral Drugs·41,572 affected·Nov 27, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml...
Medical Devices·5,000 affected·Nov 27, 2018
High RiskFDA
Medtronic Perfusion Systems
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotran...
Medical Devices·7,587 affected·Nov 27, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo ...
Medical Devices·0 affected·Nov 27, 2018
High RiskFDA
Aroa Biosurgery
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived e...
Medical Devices·8,853 affected·Nov 27, 2018
High RiskFDA
Tris Pharma Inc.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bott...
Oral Drugs·164,304 affected·Nov 26, 2018
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL O...
Oral Drugs·19,488 affected·Nov 26, 2018
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL ...
Oral Drugs·20,736 affected·Nov 26, 2018
High RiskFDA
Howmedica Osteonics Corp.
Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving ne...
Medical Devices·39 affected·Nov 26, 2018
High RiskFDA
Jackie's Cookie Connection Llc
Jackie's Cookie Babies Classic Chocolate Chip Net Wt. 28oz Manufactured and distributed by: Jackie's Cookie Connection, 12109 Santa ...
Bakery & Grains·9,720 affected·Nov 21, 2018
High RiskFDA
Titan Farms, Inc. D/b/a Palmetto Processing Solutions
Tickled PEACHES Freestone Dices; Net wt 4.4 oz. (125g) sealed plastic cups; KEEP FROZEN; Palmetto Processing Solutions 5 RW Dubose Road R...
Frozen Food·192 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Progesterone Reagent Kit, List Number 08P3620
Diagnostic Devices·157 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Diagnostic Devices·27 affected·Nov 21, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
American Contract Systems, Inc.
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP...
Cardiac Devices·51,152 affected·Nov 21, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Estradiol Reagent Kit, List Number 07P5020
Diagnostic Devices·79 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Free T4 Reagent Kit, List Number 07P7030
Diagnostic Devices·294 affected·Nov 21, 2018
High RiskFDA
Frutarom Usa Inc.
Sebastiano s Naturally Flavored Gourmet Syrups French Vanilla Naturally Sugar Free, Sweetened with Stevia; 25.4 fl. oz. (750 ml)
Food·509 affected·Nov 20, 2018
High RiskFDA
First Source, Llc
Chocolate and Nut Tray. The product comes in a four-quadrant plastic tray, NET WT 37 OZ (2 LBS 5 OZ) 1.05KG, with UPC: 0 23637 43369 0.
Snacks & Candy·229 affected·Nov 20, 2018
High RiskFDA
Avkare Inc.
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare...
Drugs·1,602 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·12,336 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, In...
Oral Drugs·48,302 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·23,478 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·25,147 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·63,213 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·12,840 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharm...
Oral Drugs·5,660 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·24,709 affected·Nov 20, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixa...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Medical Devices·3,285 affected·Nov 20, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization an...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Pharm D Solutions, Llc
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1...
Drugs·85 affected·Nov 19, 2018
High RiskFDA
Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System ...
Cardiac Devices·2,031 affected·Nov 19, 2018
High RiskFDA
Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprot...
Diagnostic Devices·250 affected·Nov 19, 2018
High RiskFDA
Arthrex, Inc.
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Nu...
Medical Devices·1,308 affected·Nov 19, 2018
High RiskFDA
Tillamook County Creamery Assoc
Chocolaty Chip Cookie Dough ice cream (item #67016), packaged in 1.75 qt. container. UPC 0 72830 07016 4. The label is read in parts: ...
Dairy·5,362 affected·Nov 16, 2018
High RiskFDA
Tillamook County Creamery Assoc
Tillamook Mudslide ice cream (item #63006), packaged in 3 gallon tub. UPC 0 72830 63006 1. The label is read in parts: "***TILLAMOOK M...
Dairy·106 affected·Nov 16, 2018
High RiskFDA
Tillamook County Creamery Assoc
Udderly Chocolate ice cream (item #67045), packaged in 1.75 qt. container. UPC 0 72830 07045 4. The label is read in parts: "***Tillam...
Dairy·6,754 affected·Nov 16, 2018