Recall: OriGen VV28F Reinforced Dual Lumen ECMO Catheters
FDA issued recall on OriGen VV28F Reinforced Dual Lumen ECMO Catheters for potential for separation of extension tube from hub.... Read More
Pharmacy Services Recalls
Recalls
Recall: Diabetes Infusion Sets by Medtronic
FDA issued recall on Diabetes Infusion Sets by Medtronic as vent membrane may be susceptible to being blocked by fluid.... Read More
Recall: Baby Organic Liquid Formula by Garden of Life
FDA issued recall on Baby Organic Liquid Formula by Garden of Life because directions for use may be misinterpreted.... Read More
Recall: Activase (alteplase) 100mg by Genentech
FDA issued recall on Activase (alteplase) 100mg by Genentech for lack of sterility assurance.... Read More
Recall: Intra-Aortic Balloon Pumps by Datascope/MAQUET
FDA issued recall on Intra-Aortic Balloon Pumps by Datascope/MAQUET for false blood detection alarm, ingress of fluid into pump.... Read More
Recall: Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium
FDA issued recall on unexpired lots of Oxytocin compounded with either lactated ringers or lactated ringers and dextrose by PharMEDium for sub-potency.... Read More
Recall: Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira
FDA issued recall on Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira for presence of particulate matter.... Read More
Recall: Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup
FDA issued recall on Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup for potential contamination with burkholderia cepacia.... Read More
Recall: Piyanping Anti-Itch Lotion
FDA issued recall on Piyanping Anti-Itch Lotion for incorrect active ingredient.... Read More
Recall: Ninjacof and Ninjacof A
FDA issued recall on Ninjacof and Ninjacof A for potential burkholderia cepacia contamination.... Read More
Recall: Sterile Drug Products by Bella Pharmaceuticals
FDA issued recall on Sterile Drug Products by Bella Pharmaceuticals for lack of sterility assurance.... Read More
Recall: Zenith Alpha Thoracic Endovascular Graft by Cook Medical
FDA issued recall on Zenith Alpha Thoracic Endovascular Graft by Cook Medical for potential formation of thrombus inside device.... Read More
Recall: Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals
FDA issued recall on Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals for misprinted dosing droppers.... Read More
Recall: Pravastatin Sodium Tablets by International Laboratories
FDA issued recall on Pravastatin Sodium Tablets by International Laboratories for mislabeling.... Read More
Recall: Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories
FDA issued recall on Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories for possible product contamination.... Read More
Recall: Diocto Liquid and Diocto Syrup by Rugby Laboratories
FDA issued recall on Diocto Liquid and Diocto Syrup by Rugby Laboratories for possible product contamination.... Read More
Recall: Man of Steel 1 and Man of Steel 2
FDA issued recall on Man of Steel 1 and Man of Steel 2 for undeclared drug ingredient.... Read More
Recall: 0.9% Sodium Chloride Injection by ICU Medical
FDA issued recall on 0.9% Sodium Chloride Injection by ICU Medical for presence of particulate matter.... Read More
Recall: Cyclobenzaprine HCl and Amantadine HCl by Apace
FDA issued recall on Cyclobenzaprine HCl and Amantadine HCl by Apace for potential mislabeling.... Read More
Recall: Sterile Drug Products by Cantrell Drug Company
FDA issued recall on Sterile Drug Products by Cantrell Drug Company for lack of sterility assurance.... Read More
Recall: La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX
FDA issued recall on La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX for undeclared drug ingredient.... Read More
Recall: Penumbra 3D Revascularization Device by Penumbra
FDA issued recall on Penumbra 3D Revascularization Device by Penumbra because wire material may break or separate during use.... Read More
Recall: ED-530XT Duodenoscopes by Fujifilm
FDA issued recall on ED-530XT Duodenoscopes by Fujifilm for updated design and labeling.... Read More
Recall: Sten Z and M1 Alpha Capsules by Andropharm
FDA issued recall on Sten Z and M1 Alpha Capsules by Andropharm for containing derivatives of anabolic steroids.... Read More
Recall: Atar Extension Cables by Oscor
FDA issued recall on Atar Extension Cables by Oscor for cable separating from connector.... Read More
Recall: Novopen Echo Insulin Delivery Device by Novo Nordisk
FDA issued recall on Novopen Echo Insulin Delivery Device by Novo Nordisk because they may crack or break If exposed to certain chemicals.... Read More
Recall: Ultra-Sten and D-Zine Capsules by Hardcore Formulations
FDA issued recall on Ultra-Sten and D-Zine Capsules by Hardcore Formulations because they contain anabolic steroids.... Read More
Recall: Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services
FDA issued recall on Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services due to potential lack of sterility assurance.... Read More
Recall: Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services
FDA issued recall on Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services due to potential lack of sterility assurance.... Read More
Recall: Potassium Phosphate and Succinylcholine by Advanced Pharma
FDA issued recall on Potassium Phosphate and Succinylcholine by Advanced Pharma due to potential lack of sterility assurance.... Read More
Recall: Potassium Phosphate and Succinylcholine by Advanced Pharma
FDA issued recall on Potassium Phosphate and Succinylcholine by Advanced Pharma due to potential lack of sterility assurance.... Read More
Recall: Venture Catheters by Vascular Solutions
FDA issued recall on Venture Catheters by Vascular Solutions because excess material may split or separate during use.... Read More
Recall: Clindamycin Injection ADD-Vantage Vials by Alvogen
FDA issued recall on Clindamycin Injection ADD-Vantage Vials by Alvogen due to lack of sterility assurance.... Read More
Recall: Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira
FDA issued recall on Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira due to potential for lack of sterility assurance.... Read More
Recall: Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals
FDA issued recall on Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals due to dissolution test failure.... Read More
Recall: Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston
FDA issued recall on Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston due to sub potency.... Read More
Recall: Topical Products by Phillips Company
FDA issued recall on Topical Products by Phillips Company due to concerns of manufacturing practices.... Read More
Recall: Eliquis (apixaban) 5 mg tablets (one lot)
FDA issued recall on one lot of Eliquis (apixaban) 5 mg tablets; bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.... Read More
Recall: SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet
FDA issued recall on SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet for potential for harmful chemicals.... Read More
Recall: Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.
FDA issued recall on Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.; out of sequence tablets and missing expiry/lot information.... Read More
Recall: Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Lot # JB5047
FDA issued recall on Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles (Lot # JB5047) due to report of another medicine in one bottle.... Read More
Recall: Caverflo Natural Herbal Coffee
FDA issued recall on Caverflo Natural Herbal Coffee for presence of undeclared active pharmaceutical ingredients.... Read More
Recall: Al-Er-G Capsules by MusclMasster
FDA issued recall on Al-Er-G Capsules by MusclMasster because they contain banned substance ephedra.... Read More
Recall: HeartMate II LVAS Pocket System Controller by Abbott-Thoratec
FDA issued recall on HeartMate II LVAS Pocket System Controller by Abbott-Thoratec due to risk of patient injury and/or death during backup controller exchange.... Read More
Recall: Tri-Ton by Dynamic Technical Formulations, LLC
FDA issued recall on Tri-Ton by Dynamic Technical Formulations, LLC because it contains andarine and ostarine drug ingredients.... Read More
Recall: V60 Non-invasive Ventilator by Respironics
FDA issued recall on V60 Non-invasive Ventilator by Respironics for unexpected device shut down.... Read More
Recall: Coronary Catheters by Abbott
FDA issued recall on Coronary Catheters by Abbott for difficulty in removing balloon sheath.... Read More
Recall: GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds
FDA issued recall on GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds for presence of anabolic steroids.... Read More
Recall: Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.)
FDA issued recall on Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) for updated controller, power management software.... Read More
Recall: Wingman35 Crossing Catheters by ReFlow Medical
FDA issued recall on Wingman35 Crossing Catheters by ReFlow Medical for tip splitting or separation.... Read More
Recall: 25% Dextrose Injection, USP (Infant) by Hospira
FDA issued recall on 25% Dextrose Injection, USP (Infant) by Hospira for particulate matter.... Read More
Recall: Phenobarbital 15 mg Tablets, USP by C.O. Truxton
FDA issued recall on Phenobarbital 15 mg Tablets, USP by C.O. Truxton for labeling error on declared strength.... Read More
Recall: Certain Homeopathic Teething Products
FDA issued recall on Certain Homeopathic Teething Products for confirmed elevated levels of belladonna.... Read More
Recall: StrataMR Adjustable Valves and Shunts by Medtronic
FDA issued recall on StrataMR Adjustable Valves and Shunts by Medtronic for potential for under-drainage of cerebrospinal fluid.... Read More
Recall: Sterile Compounded Products by Isomeric Pharmacy Solutions
FDA issued recall on Sterile Compounded Products by Isomeric Pharmacy Solutions for lack of sterility assurance.... Read More
Recall: EpiPen and and EpiPen Jr Auto-Injector
FDA issued recall on EpiPen and and EpiPen Jr Auto-Injector for failure to activate device.... Read More
Recall: Prelude Short Sheath Introducer by Merit Medical Systems
FDA issued recall on Prelude Short Sheath Introducer by Merit Medical Systems because sheath may separate during use. ... Read More
Recall: HeartStart MRx Monitor/Defibrillator by Phillips Healthcare
FDA issued recall on HeartStart MRx Monitor/Defibrillator by Phillips Healthcare for electrical issues.... Read More
Recall: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic
FDA issued recall on SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic for failure of priming bolus.... Read More
Recall: Herbal and Dietary Supplement Products by Regeneca Worldwide
FDA issued recall on Herbal and Dietary Supplement Products by Regeneca Worldwide for not being manufactured in compliance with current good manufacturing practices.... Read More
Recall: Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals
FDA issued recall on Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals for potential lack of sterility assurance.... Read More
Recall: Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”
FDA issued recall on Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free” because products may contain synthetic or natural latex.... Read More
Recall: XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.
FDA issued recall on XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc. for undeclared drug ingredient.... Read More
Recall: Comprehensive Reverse Shoulder by Zimmer Biomet
FDA issued recall on Comprehensive Reverse Shoulder by Zimmer Biomet for high fracture rate.... Read More
Recall: HCG (Human Chorionic Gonadotropin) Freeze Dried Vials
FDA issued recall on HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx for lack of sterility assurance.... Read More
Recall: Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits
FDA issued recall on Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion for alarm error.... Read More
Recall: Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL)
FDA issued recall on Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences for particulate matter.... Read More
Recall: Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement
FDA issued recall on Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc. because product contains banned ephedra alkaloids.... Read More
Recall: Standard Offset Cup Impactor with POM-C Handle
FDA issued recall on Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical for Inadequate Sterilization.... Read More