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CriticalFDA
Hi Tech Pharmaceuticals
ISOMORPH 28 PURE WHEY iSOLATE STRAWBERRY MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89866 5 & 5lb, UPC 6 49241 87835 3 jugs M...
Dairy·2 affected·Apr 3, 2021
CriticalFDA
Hi Tech Pharmaceuticals
ISOMORPH 28 PURE WHEY iSOLATE SMORES DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89002 7 jugs Manufactured By: APS Distribution, Inc. 60...
Supplements·2 affected·Apr 3, 2021
CriticalFDA
Hi Tech Pharmaceuticals
ISOMORPH 28 PURE WHEY iSOLATE ORANGE CREAMSICLE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89856 6 & 5lb, UPC 6 49241 87833 9 jugs Manu...
Supplements·2 affected·Apr 3, 2021
CriticalFDA
Hi Tech Pharmaceuticals
ISOMORPH 28 PURE WHEY iSOLATE CINNAMON GRAHAM CRACKER DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89001 0 & 5lb, UPC 6 49241 87831 5 jug...
Bakery & Grains·2 affected·Apr 3, 2021
CriticalFDA
Ummzy, Llc
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 7...
Oral Drugs·0 affected·Mar 30, 2021
CriticalFDA
Ummzy, Llc
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Oral Drugs·364 affected·Mar 30, 2021
CriticalFDA
Ummzy, Llc
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Oral Drugs·163 affected·Mar 30, 2021
CriticalFDA
Nuri Trading Llc
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Oral Drugs·0 affected·Mar 29, 2021
CriticalFDA
Nuri Trading Llc
Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Oral Drugs·0 affected·Mar 29, 2021
CriticalFDA
Nuri Trading Llc
Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Oral Drugs·0 affected·Mar 29, 2021
CriticalFDA
Nuri Trading Llc
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Oral Drugs·0 affected·Mar 29, 2021
CriticalFDA
Spartan Chemical Co Inc
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institut...
Drugs·19,044 affected·Mar 29, 2021
CriticalFDA
Sabra Dipping Company, Llc
Sabra Dipping Co, Classic Hummus ,10oz. PET cup, sealed with lid, 12 ct. Manufacturing Codes 300067. Expiration date 4/26/21
Food·2,160 affected·Mar 26, 2021
CriticalFDA
Harris Teeter
HARRIS TEETER FRESH FOODS MARKET 3 Layer COOKIES & CREME CAKE NET WT 48 OZ (3 LB) 1.36kg packages PROUDLY DISTRIBUTED BY: HARRIS TEETER, ...
Bakery & Grains·4,378 affected·Mar 26, 2021
CriticalFDA
Infusion Pump Repair
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Medical Devices·15 affected·Mar 26, 2021
CriticalFDA
Rise Baking Company
Dawn Food Products, 7 2 Layer Vanilla Bean Waterfall Cake, 35 oz., cake is placed on a cardboard plate which is then placed on a plastic...
Bakery & Grains·701 affected·Mar 25, 2021
CriticalFDA
Rise Baking Company
Dawn Food Products,8 3 Layer Cookies and Creme Cake , 35 oz., cake is placed on a cardboard plate which is then placed on a plastic plat...
Bakery & Grains·5,401 affected·Mar 25, 2021
CriticalFDA
The Biomed Guys
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alar...
Medical Devices·22 affected·Mar 25, 2021
CriticalFDA
Simply Delicious Inc.
Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best By 7/30/21 or 7/31/21.
Food·438 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordi...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: N...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, ...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactu...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: No...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk ...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: No...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Novo Nordisk Inc
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A...
Injectable Drugs·0 affected·Mar 22, 2021
CriticalFDA
Schlotterbeck & Foss, Llc
Taste of Inspirations Garlic Parmesan Wing Sauce
Food·256 affected·Mar 20, 2021
CriticalFDA
Surtidoras Bakery Inc
Oreo 3-Milk Cake (Oreo Tres Leches Cake). Cake net wt. 2.80 lbs. (1.27kg). Cake is packaged in rigid plastic dome, individually labeled, ...
Dairy·2 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·11,115,774 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·952,100 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·1,434,000 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·6,869,400 affected·Mar 19, 2021
CriticalFDA
Amra Services Ltd.
Glutenull Goji Berries & Chocolate Cookies, packaged in a clear plastic clamshell container, net wt. 11 oz. (320g). UPC 628451529132. T...
Bakery & Grains·372 affected·Mar 18, 2021
CriticalFDA
Western Mixers Produce & Nuts, Inc.
Gelson's Yogurt Raisins, Plastic Clamshell Container NET WT 14 oz. (397g) UPC: 7 97565 20470 6 Contains: Milk, Soy. Packed in a fac...
Dairy·29 affected·Mar 18, 2021
CriticalFDA
Real Water, Inc.
Real Alkalized Water, concentrate. 4 oz. glass bottle . Drinkrealwater.com
Beverages·0 affected·Mar 17, 2021
CriticalFDA
Real Water, Inc.
Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com
Beverages·0 affected·Mar 17, 2021
CriticalFDA
Alembic Pharmaceuticals Limited
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panela...
Oral Drugs·12,288 affected·Mar 17, 2021
CriticalFDA
Nuts.com
Nuts.com brand Diced Dried Figs packaged in 1lb stand up gusset pouches.
Food·20 affected·Mar 15, 2021
CriticalFDA
St. Jude Medical, Cardian Rhythm Management Division
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to p...
Cardiac Devices·95,042 affected·Mar 15, 2021
CriticalFDA
Whole Foods Market
Whole Foods Market Cranberry Biscotti PLU 41712 packaged in a clear plastic clam shell container
Produce·76 affected·Mar 11, 2021
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 2...
Drugs·42,905 affected·Mar 10, 2021
CriticalFDA
Pnhc, Llc.
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL)...
Topical Drugs·139,806 affected·Mar 10, 2021
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva 1lb and 2lb sizes in plastic tub
Food·1,320 affected·Mar 8, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva with Chocolate 1lb size in plastic tub
Snacks & Candy·600 affected·Mar 8, 2021