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High RiskFDA
Birdseed Food Co Llc
Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz. and 11 oz. poly bag, UPC: 860157002028 and 8601570020135
Bakery & Grains·440 affected·Feb 7, 2019
High RiskFDA
Willamette Valley Pie Company, Llc.
Frozen IQF Red Raspberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is 0 22518 87750 9. The lab...
Produce·1,221 affected·Feb 7, 2019
High RiskFDA
Willamette Valley Pie Company, Llc.
Frozen IQF Strawberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is UPC: 0 22518 87710 3. The...
Produce·1,448 affected·Feb 7, 2019
RecallFDA
Acp Nimble Buyer, Inc.
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Topical Drugs·58,176 affected·Feb 7, 2019
RecallFDA
Cordis Corporation
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduc...
Surgical Devices·23,481 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as ass...
Diagnostic Devices·4 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as...
Diagnostic Devices·58 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic us...
Diagnostic Devices·12 affected·Feb 7, 2019
High RiskFDA
Ecolab Inc
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-5...
Topical Drugs·105 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 4759...
Topical Drugs·30 affected·Feb 6, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use b...
Injectable Drugs·672 affected·Feb 6, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag...
Injectable Drugs·1,460 affected·Feb 6, 2019
RecallFDA
Advanced Pharma Inc.
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use b...
Injectable Drugs·12 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bo...
Topical Drugs·118 affected·Feb 6, 2019
High RiskFDA
Advanced Pharma Inc.
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, R...
Injectable Drugs·100 affected·Feb 6, 2019
RecallFDA
Dr. Reddy's Laboratories, Inc.
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10)...
Oral Drugs·40,592 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 4759...
Drugs·67 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC ...
Topical Drugs·22 affected·Feb 6, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in he...
Medical Devices·142 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Medical Devices·3 affected·Feb 6, 2019
High RiskFDA
Medica Corporation
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in w...
Diagnostic Devices·87 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Medical Devices·1 affected·Feb 6, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in ...
Medical Devices·16 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Medical Devices·4 affected·Feb 6, 2019
High RiskFDA
Abbott Ireland Diagnostics Division
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CM...
Diagnostic Devices·2,724 affected·Feb 5, 2019
High RiskFDA
Akorn Inc
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerf...
Ophthalmic Drugs·78,120 affected·Feb 4, 2019
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Injectable Drugs·475,320 affected·Feb 4, 2019
High RiskFDA
Moller Vital
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
Medical Devices·427 affected·Feb 4, 2019
High RiskFDA
Encore Medical, Lp
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Medical Devices·410 affected·Feb 4, 2019
CriticalFDA
Whole Foods Market
Whole Foods Hipster Chipster Cookies; 9 oz. container with 6 cookies; UPC 0247449 006990 Sold at Whole Foods, Yulupa Ave., Santa Rosa, CA
Bakery & Grains·8 affected·Feb 1, 2019
RecallFDA
Hikari Miso International, Inc.
Hikari Enjuku Koji Miso Mutenka; 26.6 oz. plastic tub with lid. UPC 4 905663 003007
Food·224 affected·Feb 1, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill we...
Inhaled / Nasal Drugs·10,390 affected·Feb 1, 2019
CriticalFDA
Mylan Institutional Inc
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford,...
Injectable Drugs·11,964 affected·Feb 1, 2019
RecallFDA
Lupin Pharmaceuticals Inc.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla...
Ophthalmic Drugs·43,860 affected·Feb 1, 2019
CriticalFDA
Physio-control Inc
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care respo...
Cardiac Devices·13,005 affected·Feb 1, 2019
High RiskFDA
Becton Dickinson & Company
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Medical Devices·460,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 ...
Medical Devices·26 affected·Feb 1, 2019
High RiskFDA
Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Medical Devices·428,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 ...
Medical Devices·24 affected·Feb 1, 2019
CriticalFDA
Physio-control Inc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardi...
Cardiac Devices·682 affected·Feb 1, 2019
CriticalFDA
Cook Inc.
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and in...
Cardiac Devices·100 affected·Feb 1, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - ...
Oral Drugs·10,656 affected·Jan 31, 2019
High RiskFDA
Medline Industries Inc
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box inc...
Medical Devices·750 affected·Jan 31, 2019
High RiskFDA
Dunkin Brands Inc
DUNKIN' DONUTS MULTIGRAIN BAGEL DOUGH PRODUCT APPROVED BY: DUNKIN'DONUTS Unit wt: 4.5oz Count: 104 units Net Wt: 29 lb 4 oz (13.3 kg) 007...
Food·9,779 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Salty Nuts and Seeds, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·2,597 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Oatmeal Raisin, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·3,045 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Chocolate-Maca, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·2,534 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Carrot Walnut, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·4,537 affected·Jan 30, 2019