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High RiskFDA
Vitae Enim Vitae Scientific, Inc.
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pha...
Injectable Drugs·722 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, N...
Injectable Drugs·0 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, L...
Injectable Drugs·9,800 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solu...
Injectable Drugs·5,320 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (ND...
Injectable Drugs·21,501 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (N...
Injectable Drugs·18,531 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031...
Injectable Drugs·1,980 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Cl...
Injectable Drugs·1,800 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Cl...
Injectable Drugs·670 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b)...
Injectable Drugs·2,098 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LL...
Injectable Drugs·4,270 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; ...
Surgical Devices·1,113 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model #...
Surgical Devices·17 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Medical Devices·77 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model #...
Surgical Devices·817 affected·Mar 14, 2022
High RiskFDA
Dash Pharmaceuticals Llc
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit ...
Oral Drugs·45,940 affected·Mar 11, 2022
High RiskFDA
Sartorius Corporation
Virus Counter Platform with Model Name VC3100
Medical Devices·82 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-...
Medical Devices·7 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Medical Devices·6 affected·Mar 11, 2022
High RiskFDA
Total Resources Intl
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Elect...
Medical Devices·891 affected·Mar 11, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Medical Devices·68 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Medical Devices·17 affected·Mar 11, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 721-1000, Krusteaz Belgian Waffle Mix. Product is shelf stable and packaged in a box. net wt. 28 oz., UPC 0 41449 00186 9.
Food·450 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 744-4930, Gordon Choice Southern Style Fish Breader. Product is shelf stable and packaged in a box. net wt. 5 lbs., UPC 0 93901 7...
Seafood·60 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 714-5000, Great Value Buttermilk Pancake & Waffle Mix. Product is shelf stable and packaged in a box. net wt. 32 oz., UPC 0 78742...
Dairy·1,125 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 721-0200, Krusteaz Buttermilk Pancake Mix. Product is shelf stable and packaged in a box. net wt. 2 lbs., UPC 0 41449 00110 4.
Dairy·100 affected·Mar 10, 2022
High RiskFDA
Conagra Foods, Inc.
Rosarita Organic Refried Beans Multipack carton containing 8 - 16oz cans
Food·169,680 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 722-0105, Krusteaz Cinnamon Crumb Cake. Product is shelf stable and packaged in a box. net wt. 21 oz., UPC 0 41449 11140 7.
Bakery & Grains·64 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 714-0706, Kroger Buttermilk Pancake & Waffle Mix. Product is shelf stable and packaged in a box. net wt. 2 lbs., UPC 0 11110 8821...
Dairy·1,250 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 731-0120, Krusteaz Pro Buttermilk Pancake Mix. Product is shelf stable and packaged in a box. net wt. 5 lbs., UPC 0 41449 10180 4.
Dairy·970 affected·Mar 10, 2022
High RiskFDA
Continental Mills (corporate Office)
Item # 744-4875, Gordon Choice Yellow Cake Mix. Product is shelf stable and packaged in a box. net wt. 5 lbs., UPC 0 93901 24575 5
Bakery & Grains·144 affected·Mar 10, 2022
High RiskFDA
Rock Town Distillery, Inc.
ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1...
Topical Drugs·35,468 affected·Mar 10, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Medical Implants·1 affected·Mar 10, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Medical Implants·1 affected·Mar 10, 2022
High RiskFDA
Taylor Farms
Taylor Farms - Thai Noodle Salad Kit packaged in 108oz plastic bag *Product packages all salad ingredients separate then ships to retail ...
Produce·217 affected·Mar 9, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Medical Devices·8,990 affected·Mar 9, 2022
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Medical Devices·15 affected·Mar 9, 2022
High RiskFDA
Acumed Llc
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Medical Devices·537 affected·Mar 9, 2022
High RiskFDA
Schreiber Foods Inc
Shredded Cheese consisting of Monterey Jack, Queso Quesadilla, and Asadero cheeses, Net Wt 2lbs, packaged in plastic pouches, 12 pouches ...
Dairy·3,720 affected·Mar 8, 2022
High RiskFDA
Garden Highway Southwest, Llc (ghsw, Llc)
Asian Style Noodle Salad Net Wt. 1 lb (16 oz) 463 g PERISHABLE KEEP REFRIGERATED packaged in plastic clamshells
Produce·141 affected·Mar 8, 2022
High RiskFDA
Gh Foods Ga, Llc.
Asian Style Noodle Salad, Net Wt 1lb (16oz) 453 g PERISHABLE, KEEP REFRIGERATED CONTAINS: SOY, TREE NUTS (ALMONDS), WHEAT. Distributed By...
Produce·1,421 affected·Mar 8, 2022
High RiskFDA
Taylor Farms Southwest, Inc
Thai Noodle Salad Kit 108 oz. bag (behind the counter salad), UPC 0 30223 11270 9, Taylor Farms Southwest, 859 S. 86th Ave, Tolleson, AZ ...
Produce·62 affected·Mar 8, 2022
High RiskFDA
Fairmont Foods Inc.
Schwan's Spinach & Artichoke Dip. Item Number 061353, UPC 10038-68192. Net Wt. 24 oz. (1 lb. 8 oz.) 680g. Contains: 2 Bowls. Keep ...
Dairy·1,512 affected·Mar 8, 2022
High RiskFDA
Stutzman Farms
Stutzman Farms Organic Einkorn Berries sold in bulk, or in 25lb and 50lb bags
Produce·5,000 affected·Mar 8, 2022
High RiskFDA
Stutzman Farms
Stutzman Farms Sprouted Einkorn Grate Nuts sold in .75lb and 3lb bags
Food·5,000 affected·Mar 8, 2022
High RiskFDA
Stutzman Farms
Stutzman Farms Organic All Purpose Einkorn Flour sold in bulk
Food·5,000 affected·Mar 8, 2022
High RiskFDA
Stutzman Farms
Stutzman Farms Sprouted Einkorn Crackers sold in .30lb and 1lb bags
Bakery & Grains·5,000 affected·Mar 8, 2022
High RiskFDA
Stutzman Farms
Stutzman Farms Organic All Purpose Flour sold in bulk
Food·5,000 affected·Mar 8, 2022