Skip to main content
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC...
Oral Drugs·747,464 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthc...
Injectable Drugs·5,273 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16...
Oral Drugs·992,622 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottl...
Oral Drugs·56,862 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle...
Oral Drugs·63,247 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·10,992 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, ND...
Oral Drugs·170,448 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufacture...
Oral Drugs·113,003 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufact...
Oral Drugs·37,790 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·821 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, ...
Injectable Drugs·5,090 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 1...
Oral Drugs·1,420,988 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 1672...
Oral Drugs·1,113,264 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003...
Oral Drugs·1,158,839 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC...
Injectable Drugs·23,814 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-...
Oral Drugs·88,728 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Inta...
Oral Drugs·8,184 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16...
Oral Drugs·2,731,365 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 1...
Oral Drugs·1,109,904 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16...
Oral Drugs·75,190 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: I...
Oral Drugs·181,848 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 167...
Oral Drugs·325,356 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottl...
Oral Drugs·9,600 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured ...
Oral Drugs·32,688 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·317 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Medical Devices·8,909 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·36,875 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0...
Medical Devices·11,792 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Medical Devices·47 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemo...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·200 affected·Feb 7, 2023
High RiskFDA
Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Medical Devices·415,480 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·3,177 affected·Feb 7, 2023
High RiskFDA
Power Selles Imports Dba Culinary Collective
Arroyabe Bonito Flakes White Meat Tuna Flakes in Oil From the Basque region of Spain. Product is packaged in metal can, Net wt: 32oz (900...
Meat & Poultry·28 affected·Feb 6, 2023
High RiskFDA
Alvogen, Inc
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed...
Oral Drugs·21,276 affected·Feb 6, 2023
High RiskFDA
Biomet, Inc.
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Medical Devices·12 affected·Feb 6, 2023
High RiskFDA
Sedecal Sa
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Diagnostic Devices·7 affected·Feb 6, 2023
High RiskFDA
Biomerieux Inc
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and bl...
Medical Devices·19 affected·Feb 6, 2023
High RiskFDA
Danncy Vainilla
Danncy Vainilla Pure Mexican Vanilla Extract Clear Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC 75030...
Produce·1,542 affected·Feb 5, 2023
High RiskFDA
Leadiant Biosciences, Inc.
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; D...
Injectable Drugs·31,879 affected·Feb 3, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis t...
Medical Devices·1 affected·Feb 3, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. ...
Medical Devices·129 affected·Feb 3, 2023
High RiskFDA
Tampico Spice Company Inc
Cayenne Pepper 1 pound jars, and 5 pound jars
Food·5,553 affected·Feb 2, 2023
High RiskFDA
Pilgrims Roasted Nutz
Pilgrim's Roasted Nut'Z Garlic, Parmesan, Cracked Black Pepper Hazelnuts are packaged by hand into either the 8 oz Plastic Cone Bags or 8...
Dairy·521 affected·Feb 2, 2023
High RiskFDA
W & W Dairy, Llc
El Tapatio Queso Fresco, Mexican Style Crumbling Cheese. Item 5204. UPC 0 83846-10158 2. Net Wt. 10 oz. (283g). Keep Refrigerated. M...
Dairy·2,709 affected·Feb 2, 2023
High RiskFDA
Tampico Spice Company Inc
Cajun Seasoning 1 OZ, 1 LB, 1.5 LBS, 2 LBS, 5 LBS, 6 LBS units
Food·5,553 affected·Feb 2, 2023
High RiskFDA
Pilgrims Roasted Nutz
Pilgrim's Roasted Nut'Z Creme Brulee Cashews are packaged by hand into either the 8 oz Plastic Cone Bags or 8 Oz Pouch Bags. Label declar...
Food·610 affected·Feb 2, 2023