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High RiskFDA
Torrent Pharma Inc
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) ...
Oral Drugs·438,624 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. ...
Drugs·1,500,672 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Le...
Oral Drugs·148,440 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
Drugs·24,384 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufact...
Drugs·118,080 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, ...
Inhaled / Nasal Drugs·3,788,502 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP ...
Oral Drugs·17,748 affected·May 21, 2019
High RiskFDA
Torrent Pharma Inc
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5...
Drugs·391,404 affected·May 21, 2019
High RiskFDA
Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitr...
Medical Implants·1 affected·May 21, 2019
High RiskFDA
Dutch Ophthalmic Usa, Inc.
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525...
Surgical Devices·16 affected·May 21, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Modul...
Diagnostic Devices·943 affected·May 21, 2019
High RiskFDA
Medtronic Inc
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral val...
Medical Implants·1 affected·May 21, 2019
High RiskFDA
Suja Life Llc
Suja Organic Kombucha - Ginger Lemon: 15.2 oz. glass bottle; UPC 818617020232 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CE...
Beverages·64,896 affected·May 20, 2019
High RiskFDA
Suja Life Llc
Suja Organic Kombucha - Peach Ginger: 15.2 oz. glass bottle; UPC 818617020348 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CE...
Beverages·90,489 affected·May 20, 2019
High RiskFDA
Suja Life Llc
Suja Organic Kombucha - Variety Pack: 6 x 15.2 oz. glass bottle; 2 each of Ginger Lemon, Mixes Berries and Peach Ginger UPC 8186170207...
Beverages·31,079 affected·May 20, 2019
High RiskFDA
Del Monte Fresh Produce N.a., Inc. Hq
Park Street Deli, Hummus and Veggies, Classic Hummus, Carrots & Celery NET WT 5 OZ (142g)
Food·126 affected·May 20, 2019
High RiskFDA
Suja Life Llc
Suja Organic Kombucha - Mixed Berries: 15.2 oz. glass bottle; UPC 818617020362 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 C...
Beverages·66,964 affected·May 20, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-D...
Medical Devices·4 affected·May 20, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfec...
Medical Devices·40 affected·May 20, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Banana Nut Butter Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 55140-00272. Made with organic hemp,...
Dairy·6,305 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Coconut Cashew Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00213. Display Carton UPC 10589-03007. Distributed By...
Food·2,721 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Coconut Cashew Grain-Free Granola, packaged in Net Wt. 8 oz. (227g) Re-sealable Pouch, UPC 55140-00270, and Net Wt. 16 ...
Bakery & Grains·9,732 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Chocolate Sea Salt Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00208. Display Carton UPC 10589-03006. Distribute...
Snacks & Candy·687 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 10589-03015. made with org...
Bakery & Grains·2,545 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
GreenWise Cranberry Cashew Granola, Net Wt. 12 oz. (340g) Re-sealable Pouch. UPC 41415-18305. Made with organic oats. Distributed by P...
Bakery & Grains·4,164 affected·May 17, 2019
High RiskFDA
Oakhouse Bakery
purely elizabeth Banana Nut Butter Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00209. Display Carton UPC 10589-03005. Distributed...
Dairy·952 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device...
Diagnostic Devices·50 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Covidien Llc
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Medical Devices·3,113,280 affected·May 17, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal V...
Medical Devices·292 affected·May 17, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE ALMOND CHOCOLATE MEIJI, 3.1 oz. Item number 64344 UPC 074410643447 - only on those bars with English labeling. Distribut...
Snacks & Candy·142 affected·May 16, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE CHOCO BABY (S) MEIJI, 1.19 oz. Item number 70582 UPC 074410705824 - only on those bars with English labeling. Distribute...
Snacks & Candy·61 affected·May 16, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE KINOKO NO YAMA MEIJI, 2.61 oz. Item number 65879 UPC 074410658793 - only on those bars with English labeling. Distribute...
Snacks & Candy·40 affected·May 16, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE TAKENOKO NO SATO MEIJI (Chocolate wheat snack, 2.46 oz. Item number 65880 UPC 074410658809 - only on those bars with Englis...
Snacks & Candy·94 affected·May 16, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE MACADAMIA MEIJI, 2.25 oz. Item number 69920 UPC 074410699208 - only on those bars with English labeling. Distributed by ...
Snacks & Candy·103 affected·May 16, 2019
High RiskFDA
Wismettac Asian Foods, Inc
CHOCOLATE BLACK CHOCOLATE MEIJI, 1.75 oz. Item number 69341 UPC 074410693411 - only on those bars with English labeling. Distribut...
Snacks & Candy·50 affected·May 16, 2019
High RiskFDA
Codman & Shurtleff Inc
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Medical Devices·28 affected·May 16, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthc...
Medical Devices·145 affected·May 16, 2019
High RiskFDA
Ge Healthcare, Llc
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in t...
Medical Devices·82 affected·May 16, 2019
High RiskFDA
Regal Food Inc./dba The Pizza Shop
Regal's Fundraising Cookies: Cornflake flavor. Net Weight 12 oz. (340 grams). All varieties have the same ingredient list: Flour, Su...
Dairy·0 affected·May 15, 2019
High RiskFDA
Aps Biogroup, Inc
Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml)
Supplements·7,132 affected·May 15, 2019