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RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Medical Devices·22,320 affected·Oct 9, 2018
High RiskFDA
Theragenics Corporation
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic n...
Medical Devices·480 affected·Oct 9, 2018
CriticalFDA
Synaptive Medical Inc
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-...
Medical Devices·37 affected·Oct 9, 2018
CriticalFDA
Kemps, Llc
Sweet Me Creamery Brookie Dough ice cream, packaged in following configuration: 1 Pint (473 ML), UPC: 41483-04219 or 4-Pack of 1 Pint (4...
Dairy·79,240 affected·Oct 8, 2018
High RiskFDA
Forager Project Llc
Forager Project Organic Protein Plant Shake Nuts & Vanilla 12 fl oz. UPC: 8 14558 02038 6
Food·2,256 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL ...
Injectable Drugs·2,580,448 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Injectable Drugs·372,912 affected·Oct 8, 2018
High RiskFDA
Akorn, Inc.
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 1...
Ophthalmic Drugs·149,159 affected·Oct 8, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Medical Devices·20,030 affected·Oct 8, 2018
High RiskFDA
Voluntis
Insulia Diabetes Management Companion
Diabetes Devices·14 affected·Oct 8, 2018
CriticalFDA
Bazzini Llc
BAZZINI S ROASTED & SALTED IN-SHELL SUPER COLOSSAL PISTACHIOS 25 LB BULK BOX UPC #0 75062 30700 8
Food·4,000 affected·Oct 6, 2018
CriticalFDA
Bazzini Llc
BAZZINIS ROASTED & SALTED IN-SHELL PISTACHIOS RAMS HEAD NATURAL 16 OZ BAG UPC #0 75062 00536 2 THE BAGS ARE RED, WHITE AND BLUE.
Food·4,000 affected·Oct 6, 2018
CriticalFDA
Bazzini Llc
BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS SUPER COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30701 5 THE BAGS ARE RED, WHITE AND BLUE.
Food·4,000 affected·Oct 6, 2018
CriticalFDA
Bazzini Llc
BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS COLOSSAL NATURAL 16 OZ BAG UPC #0 75062 00535 5 THE BAGS ARE RED, WHITE AND BLUE.
Food·4,000 affected·Oct 6, 2018
CriticalFDA
Bazzini Llc
BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30711 4 THE BAGS ARE RED, WHITE AND BLUE.
Food·4,000 affected·Oct 6, 2018
CriticalFDA
Ladyfingers Catering, Llc
LADYFINGERS GOURMET TO GO SIGNATURE SHAVED COUNTRY HAM ROLLS; ONE DOZEN PER PACKAGE (15oz - 425 grams); ALLERGEN INFORMATION: CONTAINS WH...
Produce·50,627 affected·Oct 5, 2018
High RiskFDA
Lupin Somerset
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufac...
Topical Drugs·2,712 affected·Oct 5, 2018
RecallFDA
Amerigen Pharmaceuticals Inc.
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: S...
Oral Drugs·5,232 affected·Oct 5, 2018
RecallFDA
Orexigen Therapeutics, Inc.
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen the...
Oral Drugs·18,895 affected·Oct 5, 2018
RecallFDA
Tosoh Bioscience Inc
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for...
Medical Devices·1,000 affected·Oct 5, 2018
CriticalFDA
Ge Healthcare, Llc
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) ...
Respiratory Devices·1,140 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Medical Devices·25,640 affected·Oct 5, 2018
High RiskFDA
Ohmeda Medical
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as ...
Respiratory Devices·0 affected·Oct 5, 2018
High RiskFDA
Covidien Llc
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circul...
Surgical Devices·7,333 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Medical Devices·27,250 affected·Oct 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Medical Devices·264 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Medical Devices·1,760 affected·Oct 5, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Cuban Style Sub, NET WT 8.3 OZ (235g), UPC 72251525152
Food·2,600 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Country Ham on Petite Party Rolls 20CT, NET WT 17.7 OZ (1.11lb/502g), UPC 72251524487
Food·35 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Country Ham on Petite Biscuits 8CT, NET WT 14 OZ (397g), UPC 72251524271
Food·88 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Honey Turkey & Cheddar on White House Rolls 2CT, NET WT 5.5 OZ (155g), UPC 72251525074
Meat & Poultry·6,152 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Black Forest Ham & Provolone Sub NET WT 7.8 OZ (221g) UPC 72251525153
Food·2,702 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Honey Ham & Turkey on White House Rolls 4CT, NET WT 11 OZ (311g), UPC 72251525071
Meat & Poultry·3,400 affected·Oct 4, 2018
CriticalFDA
Callie's Charleston Biscuits
Callie's Charleston Biscuits COUTRY HAM BISCUITS; 18 NET WT. 18 OZ (510 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 1...
Food·12,072 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Ham on White House Rolls 12CT, NET WT 26.9 OZ (1.68lb/762g) UPC 72251525154 ,
Food·67 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Ham on Petite Party Rolls 20CT, NET WT 21.8 OZ (1.36lb/618g) , UPC 72251524094
Food·44 affected·Oct 4, 2018
CriticalFDA
Callie's Charleston Biscuits
Callie's Charleston Biscuits COCKTAIL HAM BISCUITS; 24 NET WT. 35 OZ (980 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC...
Food·3,022 affected·Oct 4, 2018
High RiskFDA
Campofresco Corp.
Orange plus Citrus Beverage from Concentrate
Beverages·1,010 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Roasted Turkey & Colby Jack Sub, NET WT 8.3 OZ (235g), UPC 72251525142
Meat & Poultry·4,668 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Italian Style Sub , NET WT 8.2 OZ (232g) UPC 72251525151
Food·6,602 affected·Oct 4, 2018
CriticalFDA
Ukrop's Homestyle Foods, Llc
Ukrop's Country Ham on White House Rolls 12CT, 2CT, 6CT, NET WT 23.3 OZ (1.46lb/660g), NET WT 3.9 OZ (110g), NET WT 11.6 OZ (330g), UPC 7...
Food·3,595 affected·Oct 4, 2018
RecallFDA
K.b. Pizza, Inc.
Son of Italy, Twin Pack Cheese Pizza Kit, 39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
Dairy·120 affected·Oct 3, 2018
RecallFDA
K.b. Pizza, Inc.
Son of Italy Pepperoni Pizza Kit ,39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
Food·144 affected·Oct 3, 2018
CriticalFDA
Silver Star Brands
Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
Oral Drugs·53 affected·Oct 3, 2018
RecallFDA
Invagen Pharmaceuticals, Inc.
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipl...
Oral Drugs·2,880 affected·Oct 3, 2018
CriticalFDA
Silver Star Brands
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
Oral Drugs·95 affected·Oct 3, 2018
CriticalFDA
Silver Star Brands
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-1...
Oral Drugs·931 affected·Oct 3, 2018
High RiskFDA
Silver Star Brands
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-2...
Oral Drugs·247 affected·Oct 3, 2018