FDA issued recall on CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp. due to fluid ingress that may affect device operation and interrupt or delay therapy.... Read More
FDA issued recall on naloxone hydrochloride injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira due to the potential presence of particulate matter.... Read More
FDA issued recall on HeartWare HVAD system by Medtronic due to unintended intermittent electrical disconnection between the power source and the controller.... Read More
FDA issued recall on STAT-Check and Medline manual resuscitator bags by SunMed Holdings due to patient port may detach during use.... Read More
FDA issued recall on Fluticasone propionate nasal spray by Apotex Corp due to potential for small glass particles.... Read More
FDA issued recall on TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan due to out of sequence capsules.... Read More
FDA issued recall on X-Jow and Acne Shave products by Shadow Holdings due to possible bacterial contamination.... Read More
FDA issued recall on 95% ethyl alcohol product by Ethanol Extraction due to a possible contamination with methanol.... Read More
FDA issued recall on HeartMate 3™ Left Ventricular Assist System due to potential malfunction that may lead to graft occlusion.... Read More
FDA issued recall on homeopathic teething drops, nausea drops, intestinal colic drops, stomach calm, expectorant cough syrup, silver-zinc throat spray, and argentum elixir by MBI Distributing due to a lack of adequate controls.... Read More
FDA issued recall on 7K and Poseidon 4500 by Shoreside Enterprises due to presence of undeclared sildenafil and/or tadalafil.... Read More
FDA issued recall on MindFrame Capture LP Revascularization Device by Medtronic due to wire material that may break or separate during use.... Read More
FDA issued recall on Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical due to risk of malfunction caused by error in product design.... Read More
FDA issued recall on Fabius Anesthesia Machines by Dräger Medical due to production step error.... Read More
FDA issued recall on ampicillin and sulbactam for injection USP, 3 g single-dose vials by AuroMedics Pharma due to red particulate matter.... Read More
FDA issued recall on piperacillin and tazobactam for injection, USP 3.375 g vials by AuroMedics Pharma due to particulate matter.... Read More
FDA issued recall on NxtGen Botanicals Maeng Da Kratom by NGB Corp. due to possible salmonella contamination.... Read More
FDA issued recall on certain kratom-containing powder products by Viable Solutions due to possible salmonella contamination.... Read More
FDA issued recall on all products marketed as sterile by Coastal Meds due to visible particles in some of the drug vials for injection.... Read More
FDA issued recall on Acrodose PLus and PL systems by Haemonetics due to low pH readings for platelets stored in CLX HP Bag.... Read More
FDA issued recall on sterile injectable products by Premier Pharmacy Labs due to lack of sterility assurance.... Read More
FDA issued recall on Maeng Da Red powder and capsules by Club 13 due to possible contamination with salmonella.... Read More
FDA issued recall on kratom-containing products by Triangle Pharmanaturals due to risk of salmonella.... Read More
FDA issued recall on Dietary supplements by Nutrizone due to potential for salmonella contamination.... Read More
FDA issued recall on Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA due to possible potential contamination.... Read More
FDA issued recall on Eclipse Kratom by Tamarack due to possible salmonella contamination.... Read More
FDA issued recall on BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD) due to chemical interference with certain tests.... Read More
FDA issued recall on NeuroBlate Probe by Monteris Medical due to unintended heating.... Read More
FDA issued recall on Alka-Seltzer Plus products because ingredients on front sticker may not match product in carton.... Read More
FDA issued recall on kratom-containing powder products by PDX Aromatics due to potential for contamination with salmonella.... Read More
FDA issued recall on methylprednisolone sodium succinate for injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals due to high out of specification impurity results.... Read More
FDA issued recall on hydromorphone hcl injection USP by Hospira due to potential for empty or cracked glass vials.... Read More
FDA issued recall on Bella Diet Capsules by Bella All Natural due to presence of sibutramine.... Read More
FDA issued recall on Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic because manufacturing error preventing electrical shock delivery.... Read More
FDA issued recall on labetalol hydrochloride Injection by Hospira due to potential for cracked glass at rim surface of vials.... Read More
FDA issued recall on Acyclovir 400 mg Tablets by Apace Packaging due to product mix-up.... Read More
FDA issued recall on HeartStart MRx Defibrillator by Philips Electronics because defects in gas discharge tubes may cause device failure.... Read More
FDA issued recall on Gericare Eye Wash by Kareway Products due to potential product contamination.... Read More
FDA issued recall on AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical due to manufacturing error.... Read More
FDA issued recall on multiple drug products by Flawless Beauty because they are misbranded or unapproved.... Read More
FDA issued recall on Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories due mislabeling.... Read More
FDA issued recall on Levofloxacin in 5 percent dextrose 250mg/50mL by AuroMedics due to presence of visible particulate matter.... Read More
FDA issued recall on Certitude Delivery System by Edwards Lifesciences due to mold overflow defect which may obstruct blood flow.... Read More
FDA issued recall on Clopidogrel tablets USP, 75 mg by International Laboratories due to product mislabeling.... Read More
FDA issued recall on ampicillin and sulbactam for injection USP 1.5 g/vial by Auromedics due to presence of glass particles in vial.... Read More
FDA issued recall on compounded sterile products by PharMEDium Services due to lack of sterility assurance.... Read More
FDA issued recall on reprocessed Agilis Steerable introducer sheath by Sterilmed due to improper seal of sheath hub.... Read More
FDA issued recall on linezolid injection 600mg/300mL flexible bags due to presence white particle matter that has been identified as mold.... Read More
FDA issued recall on pantoprazole sodium for injection 40mg per vial for presence of glass particles.... Read More
FDA issued recall on defibrillation electrodes for Lifepak AEDs by Physio-Control for incorrect placement instructions for infants depicted on artwork.... Read More
FDA issued recall on Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics for lack of sterility assurance and other quality issues.... Read More
FDA issued recall on Riomet (Metformin Hydrochloride Oral Solution) for microbial contamination.... Read More
FDA issued recall on Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone for possible sub potent and super potent tablets.... Read More
FDA issued recall on Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection for presence of particulate matter.... Read More
FDA issued recall on Ridge Properties DBA Pain Relief Naturally Products for manufacturing concerns.... Read More
FDA issued recall on Midazolam Injection, USP, 2 mg/2 mL mL by Fresenius Kabi for reports of blister packages containing syringes of ondansetron injection.... Read More
Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots.... Read More
FDA issued recall on injectable products by SCA Pharmaceuticals for potential contamination.... Read More
FDA issued recall on Intralipid 20% IV Fat Emulsion by Baxter because one shipment of product exposed to subfreezing temperatures.... Read More
FDA issued recall on Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics for risk of blocked guidewire lumen preventing balloon utilization.... Read More
FDA issued recall on OriGen VV28F Reinforced Dual Lumen ECMO Catheters for potential for separation of extension tube from hub.... Read More
FDA issued recall on Diabetes Infusion Sets by Medtronic as vent membrane may be susceptible to being blocked by fluid.... Read More
FDA issued recall on Baby Organic Liquid Formula by Garden of Life because directions for use may be misinterpreted.... Read More
FDA issued recall on Activase (alteplase) 100mg by Genentech for lack of sterility assurance.... Read More
FDA issued recall on Intra-Aortic Balloon Pumps by Datascope/MAQUET for false blood detection alarm, ingress of fluid into pump.... Read More
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
FDA issued recall on Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira for presence of particulate matter.... Read More
FDA issued recall on Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup for potential contamination with burkholderia cepacia.... Read More
FDA issued recall on Piyanping Anti-Itch Lotion for incorrect active ingredient.... Read More
FDA issued recall on Ninjacof and Ninjacof A for potential burkholderia cepacia contamination.... Read More
FDA issued recall on Sterile Drug Products by Bella Pharmaceuticals for lack of sterility assurance.... Read More
FDA issued recall on Zenith Alpha Thoracic Endovascular Graft by Cook Medical for potential formation of thrombus inside device.... Read More
FDA issued recall on Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals for misprinted dosing droppers.... Read More
FDA issued recall on Pravastatin Sodium Tablets by International Laboratories for mislabeling.... Read More
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
FDA issued recall on Diocto Liquid and Diocto Syrup by Rugby Laboratories for possible product contamination.... Read More
FDA issued recall on Man of Steel 1 and Man of Steel 2 for undeclared drug ingredient.... Read More
FDA issued recall on 0.9% Sodium Chloride Injection by ICU Medical for presence of particulate matter.... Read More
FDA issued recall on Cyclobenzaprine HCl and Amantadine HCl by Apace for potential mislabeling.... Read More
FDA issued recall on Sterile Drug Products by Cantrell Drug Company for lack of sterility assurance.... Read More
FDA issued recall on La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX for undeclared drug ingredient.... Read More
FDA issued recall on Penumbra 3D Revascularization Device by Penumbra because wire material may break or separate during use.... Read More
FDA issued recall on ED-530XT Duodenoscopes by Fujifilm for updated design and labeling.... Read More
FDA issued recall on Sten Z and M1 Alpha Capsules by Andropharm for containing derivatives of anabolic steroids.... Read More
FDA issued recall on Atar Extension Cables by Oscor for cable separating from connector.... Read More
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
FDA issued recall on Ultra-Sten and D-Zine Capsules by Hardcore Formulations because they contain anabolic steroids.... Read More
FDA issued recall on Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services due to potential lack of sterility assurance.... Read More
FDA issued recall on Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services due to potential lack of sterility assurance.... Read More
FDA issued recall on Potassium Phosphate and Succinylcholine by Advanced Pharma due to potential lack of sterility assurance.... Read More
FDA issued recall on Potassium Phosphate and Succinylcholine by Advanced Pharma due to potential lack of sterility assurance.... Read More
FDA issued recall on Venture Catheters by Vascular Solutions because excess material may split or separate during use.... Read More
FDA issued recall on Clindamycin Injection ADD-Vantage Vials by Alvogen due to lack of sterility assurance.... Read More
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
FDA issued recall on Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals due to dissolution test failure.... Read More
FDA issued recall on Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston due to sub potency.... Read More
FDA issued recall on Topical Products by Phillips Company due to concerns of manufacturing practices.... Read More
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
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
FDA issued recall on Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.; out of sequence tablets and missing expiry/lot information.... Read More
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
FDA issued recall on Caverflo Natural Herbal Coffee for presence of undeclared active pharmaceutical ingredients.... Read More
FDA issued recall on Al-Er-G Capsules by MusclMasster because they contain banned substance ephedra.... Read More
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
FDA issued recall on Tri-Ton by Dynamic Technical Formulations, LLC because it contains andarine and ostarine drug ingredients.... Read More
FDA issued recall on V60 Non-invasive Ventilator by Respironics for unexpected device shut down.... Read More
FDA issued recall on Coronary Catheters by Abbott for difficulty in removing balloon sheath.... Read More
FDA issued recall on GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds for presence of anabolic steroids.... Read More
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
FDA issued recall on Wingman35 Crossing Catheters by ReFlow Medical for tip splitting or separation.... Read More
FDA issued recall on 25% Dextrose Injection, USP (Infant) by Hospira for particulate matter.... Read More
FDA issued recall on Phenobarbital 15 mg Tablets, USP by C.O. Truxton for labeling error on declared strength.... Read More
FDA issued recall on Certain Homeopathic Teething Products for confirmed elevated levels of belladonna.... Read More
FDA issued recall on StrataMR Adjustable Valves and Shunts by Medtronic for potential for under-drainage of cerebrospinal fluid.... Read More
FDA issued recall on Sterile Compounded Products by Isomeric Pharmacy Solutions for lack of sterility assurance.... Read More
FDA issued recall on EpiPen and and EpiPen Jr Auto-Injector for failure to activate device.... Read More
FDA issued recall on Prelude Short Sheath Introducer by Merit Medical Systems because sheath may separate during use. ... Read More
FDA issued recall on HeartStart MRx Monitor/Defibrillator by Phillips Healthcare for electrical issues.... Read More
FDA issued recall on SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic for failure of priming bolus.... Read More
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
FDA issued recall on Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals for potential lack of sterility assurance.... Read More
FDA issued recall on Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free” because products may contain synthetic or natural latex.... Read More
FDA issued recall on XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc. for undeclared drug ingredient.... Read More
FDA issued recall on Comprehensive Reverse Shoulder by Zimmer Biomet for high fracture rate.... Read More
FDA issued recall on HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx for lack of sterility assurance.... Read More
FDA issued recall on Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion for alarm error.... Read More
FDA issued recall on Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences for particulate matter.... Read More
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
FDA issued recall on Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical for Inadequate Sterilization.... Read More