Recall: Raindrop Near Vision Inlay by RVO 2.0
FDA issued recall of Raindrop Near Vision Inlay by RVO 2.0 due to corneal haze.... Read More
Pharmacy Services Recalls
Recalls
Recall: Kratom Products by Sunstone Organics
FDA issued recall of Kratom products by Sunstone Organics due to salmonella.... Read More
Recall: Drospirenone and Ethinyl Estradiol Tablets by Apotex Corp
FDA issued recall of drospirenone and ethinyl estradiol tablets by Apotex Corp due to missing/Incorrect tablet arrangement.... Read More
Recall: LIFEPAK15 by Physio-Control
FDA issued recall of LIFEPAK15 by Physio-Control due to risk of device failure.... Read More
Recall: GoLean Detox Capsules by GoLean Detox USA
FDA issued recall of GoLean Detox capsules by GoLean Detox USA due to undeclared ingredients.... Read More
Recall: Losartan Potassium/Hydrochlorothiazide Tablets by Macleods Pharmaceuticals
FDA issued recall of losartan potassium/hydrochlorothiazide tablets, 100mg/25mg by Macleods Pharmaceuticals due to NDEA impurity. ... Read More
Recall: ChemoLock Vial Spike by ICU Medical
FDA issued recall of ChemoLock Vial Spike by ICU Medical due to particle risk. ... Read More
Recall: Dual Chamber Implantable Pulse Generators by Medtronic
FDA issued recall of dual chamber implantable pulse generators by Medtronic due to circuit error. ... Read More
Recall: Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL by Dr. Reddy's Laboratories
FDA issued recall of levetiracetam in 0.54% sodium chloride injection 1500mg/100mL by Dr. Reddy's Laboratories due to mislabeling. ... Read More
Recall: Swan-Ganz Thermodilution Catheter by Edwards Lifesciences
FDA issued recall of Swan-Ganz thermodilution catheter by Edwards Lifesciences due to incorrect assembly. ... Read More
Recall: Sterile Saline and Sterile Water for Inhalation by Medex Cardio-Pulmonary, Doing Business as Smiths Medical
FDA issued recall of sterile saline and sterile water for inhalation by Medex Cardio-Pulmonary, doing business as Smiths Medical due to potential exposure to infectious agents as a result of leaking containers. ... Read More
Recall: LIFEPAK® 15 Monitor/Defibrillator by Stryker
FDA issued recall of LIFEPAK® 15 monitor/defibrillator by Stryker due to lock up after a defibrillation shock is delivered. ... Read More
Recall: CoaguChek XS PT Test Strips by Roche Diagnostics
FDA issued recall of CoaguChek XS PT Test Strips by Roche Diagnostics due to inaccurate test results. ... Read More
Recall: Vial2Bag Fluid Transfer Systems by West Pharmaceutical Services
FDA issued recall of Vial2Bag fluid transfer systems by West Pharmaceutical Services due to potential malfunctions. ... Read More
Recall: Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma - UPDATE
FDA issued recall of Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma due to potential higher concentrations of ibuprofen; three additional lots added. ... Read More
Recall: Silver Bullet 10x by Nature’s Rx
FDA issued recall of Silver Bullet 10x by Nature’s Rx due to undeclared PDF-5 inhibitors. ... Read More
Recall: VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical
FDA issued recall of VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical due to possible incorrect assembly. ... Read More
Recall: Irbesartan and Irbesartan/Hydrochlorothiazide (HCTZ) Tablets by Prinston Pharmaceutical
FDA issued recall of irbesartan and irbesartan/hydrochlorothiazide (HCTZ) tablets by Prinston Pharmaceutical due to NDEA impurity.... Read More
Recall: Synergy Cranial Software and Stealth Station S7 Cranial Software by Medtronic
FDA issued recall of Synergy Cranial software and Stealth Station S7 Cranial software by Medtronic due to inaccuracies displayed during surgical procedures.... Read More
Recall: Rhino 5k Capsules by Happy Together
FDA issued recall of Rhino 5k capsules by Happy Together due to presence of undeclared sildenafil and tadalafil.... Read More
Recall: Vecuronium Bromide for Injection by Sun Pharmaceutical Industries
FDA issued recall of vecuronium bromide for injection by Sun Pharmaceutical Industries due to particulate matter.... Read More
Recall: Ceftriaxone for Injection by Lupin Pharmaceuticals
FDA issued recall of ceftriaxone for injection by Lupin Pharmaceuticals due to particulate matter.... Read More
Recall: Losartan Potassium Tablets, USP by Torrent Pharmaceuticals Limited
FDA issued recall of losartan potassium tablets, USP by Torrent Pharmaceuticals Limited due to impurity.... Read More
Recall: Amlodipine/Valsartan Tablets USP, Valsartan/HCTZ Tablets, USP and Valsartan Tablets USP by Aurobindo
FDA issued recall of CAmlodipine/Valsartan Tablets USP, Valsartan/HCTZ Tablets, USP and Valsartan Tablets USP by Aurobindo due to NDEA (N-Nitrosodiethylamine) impurity.... Read More
Recall: CoaguChek XS PT Test Strips by Roche Diagnostics
FDA issued recall of CoaguChek XS PT Test Strips by Roche Diagnostics due to inaccurate INR test results.... Read More
Recall: Some Dyural-40 and Dyural-80 convenience kits by Enovachem Pharmaceuticals
FDA issued recall of Dyural-40 and Dyural-80 convenience kits containing recalled sodium chloride injection by Enovachem Pharmaceuticals due to latex hazard.... Read More
Recall: CareScape R860 Inspiratory Safety Guard by GE Healthcare
FDA issued recall of CareScape R860 Inspiratory Safety Guard by GE Healthcare due to breathing circuit disconnection risk.... Read More
Recall: Kotex Sleek Tampons, Regular Absorbency by Kimberly-Clark
FDA issued recall of Kotex Sleek Tampons, Regular Absorbency by Kimberly-Clark due to quality-related defect .... Read More
Recall: Infants’ Ibuprofen Concentrated Oral Suspension by: Tris Pharma
FDA issued recall of infants’ ibuprofen concentrated oral suspension (50 mg per 1.25 mL) by Tris Pharma due to incorrect concentrations.... Read More
Recall: Spinal Fusion and Long Bone Stimulators by Zimmer Biomet
FDA issued recall of spinal fusion and long bone stimulators by Zimmer Biomet due to manufacturing issues.... Read More
Recall: BrightMatter Guide with SurfaceTrace Registration by Synaptive Medical
FDA issued recall of BrightMatter Guide with SurfaceTrace Registration by Synaptive Medical due to software defect.... Read More
Recall: Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets by Teva Pharmaceuticals USA
FDA issued recall of all amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets by Teva Pharmaceuticals USA due to an impurity.... Read More
Recall: ThermaCare HeatWraps by Pfizer
FDA issued recall of six lots of ThermaCare HeatWraps by Pfizer due to skin injury potential.... Read More
Recall: EPICS by Beckman Coulter Life Sciences
FDA issued recall of FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) by Beckman Coulter Life Sciences due to product failure.... Read More
Recall: Sodium Chloride Injection, USP, 0.9% by Fresenius Kabi
FDA issued recall of Sodium Chloride Injection, USP, 0.9% by Fresenius Kabi due to incorrect product labeling.... Read More
Recall: TB Temporary Bipolar Pacing Leads by Oscor
FDA issued recall of TB Temporary Bipolar Pacing Leads by Oscor due to connector separation.... Read More
Recall: EPICS XL Series Flow Cytometers by Beckman Coulter Life Sciences
FDA issued recall of EPICS XL Series flow cytometers by Beckman Coulter Life Sciences due to inaccurate results.... Read More
Recall: Valsartan-containing products by Mylan
FDA issued recall of valsartan-containing products by Mylan due to trace amounts of N-nitrosodiethylamine.... Read More
Recall: TB Unshrouded Bipolar Pacing Lead by Oscor
FDA issued recall of TB Unshrouded Bipolar Pacing Lead by Oscor due to possible connector cap movement and connection wire exposure.... Read More
Recall: Millennium Nuclear Medicine Systems by GE Healthcare
FDA issued recall of Millennium Nuclear Medicine Systems by GE Healthcare due to risk of detector detaching and falling.... Read More
Recall: Losartan Potassium and Hydrochlorothiazide by Sandoz
FDA issued recall of losartan potassium and hydrochlorothiazide by Sandoz due to trace amounts of NDEA (N-Nitrosodiethylamine).... Read More
Recall: Puriton Eye Relief Drops by Kadesh Incorporation
FDA issued recall of Puriton Eye Relief Drops by Kadesh Incorporation due to non-sterile production conditions.... Read More
Recall: CoaguChek XS PT Test Strips by Roche Diagnostics
FDA issued recall of CoaguChek XS PT Test Strips by Roche Diagnostics due to inaccurate INR test results.... Read More
Recall: Irbesartan Tablets by Sciegen Pharmaceuticals
FDA issued recall of irbesartan tablets by Sciegen Pharmaceuticals due to detection of trace amounts of NDEA (N-Nitrosodiethylamine).... Read More
Recall: Prednisolone and Gatifloxacin Ophthalmic Solution
FDA issued recall of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile, 3 mL vials by Promise Pharmacy due to small particulate floating in the solution.... Read More
Recall: Zero Xtreme by Fat Burners Zone
FDA issued recall of Zero Xtreme by Fat Burners Zone due to presence of undeclared sibutramine.... Read More
Recall: AFX Endovascular AAA Systems by Endologix
FDA issued recall of AFX Endovascular AAA Systems by Endologix due to risk of type III endoleaks .... Read More
Recall: Regen Series Product by Liveyon
FDA issued recall of Regen Series product by Liveyon (manufactured by Genetech, Inc.) due to reported possible adverse reactions.... Read More
Recall: Homeopathic Aqueous-Based Medicines by Eight and Company LLC (Sprayolog)
FDA issued recall of homeopathic aqueous-based medicines by Eight and Company, d/b/a Sprayolog due to microbial contamination.... Read More
Recall: Human and Animal Drug Products by Silver Star Brands
FDA issued recall of human and animal drug products by Silver Star Brands due to microbial contamination.... Read More
Voluntary Nationwide Recall: Robaxin® 750mg Tablets by Endo Pharmaceuticals
Endo Pharmaceuticals issues voluntary nationwide recall of two lots of Robaxin® 750mg tablets 100 count bottle packs due to incorrect daily dosing information on label.... Read More
Voluntary Nationwide Recall: NeoRelief for Muscle Cramping and Restlessness by BioLyte Laboratories
BioLyte Laboratories issues voluntary nationwide recall of NeoRelief for muscle cramping and restlessness topical gel due to possible microbial contamination.... Read More
Voluntary Nationwide Recall: All Sterile Compounded Drugs by Pharm D Solutions, LLC
Pharm D Solutions, LLC issues voluntary nationwide recall of all sterile compounded drugs due to potential lack of sterility assurance.... Read More
Recall: Homeopathic Aqueous/Alcohol-Based Medicines by Beaumont Bio Med
FDA issued recall of homeopathic aqueous/alcohol-based medicines by Beaumont Bio Med due to possible microbial contamination.... Read More
Recall: Tri-Flo Subglottic Suction System by Vyaire Medical
FDA issued recall of Tri-Flo Subglottic Suction System by Vyaire Medical due to risk of device breakage.... Read More
Voluntary Withdrawal: CyPass Micro-Stent by Alcon
Alcon issues voluntary global withdrawal of CyPass Micro-Stent for surgical glaucoma due to statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.... Read More
Recall: CPAP Mask Cushion Devices by Compass Health Brands
Compass Health Brands recall of CPAP mask cushion devices due to possible air leaks.... Read More
Neuroveen, Respitrol, Thyroveev, and Compulsin by Hellolife, Inc.
Hellolife, Inc. issues voluntary nationwide recall of Neuroveen, Respitrol, Thyroveev, and Compulsin due to possible microbial contamination.... Read More
Recall: Nasal Products and Baby Oral Gels by Product Quest Manufacturing
FDA issued recall of nasal products and baby oral gels by Quest Manufacturing due to possible microbial contamination.... Read More
Recall: Children’s Advil by Pfizer
FDA issued recall of Children’s Advil by Pfizer Lot# R51129 due to dosage cup mislabeling.... Read More
Recall: Hydrochlorothiazide Tablets USP 12.5 Mg by Accord Healthcare
FDA issued recall of Hydrochlorothiazide Tablets USP 12.5 Mg by Accord Healthcare due to labeling mix-up.... Read More
Recall: Weight Away Remedy by Living Well Remedies
FDA issued recall of Weight Away Remedy by Living Well Remedies due to microbial contamination.... Read More
Recall: Leukotrap RC System with RC2D Filter by Haemonetics Manufacturing
FDA issued recall of Leukotrap RC System with RC2D filter by Haemonetics Manufacturing due to reports of higher than expected residual WBC.... Read More
Recall: Antimicrobial Susceptibility Testing Cards by BioMerieux
FDA issued recall of VITEK 2 Gram Positive antimicrobial susceptibility testing cards by BioMerieux due to False Results for some strains of methicillin-resistant Staphylococcus aureus.... Read More
Voluntary Recall: King Bio Kids and Infant Products
King Bio issues voluntary nationwide recall of kids and infant products due to potential microbial contamination.... Read More
Recall: Porcine Thyroid API from Sichuan Friendly Pharmaceutical Co
FDA issued recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co due to inconsistent potency in the active ingredient.... Read More
Recall: World Organix, LLC Blissful Remedies
World Organix, LLC issues voluntary nationwide recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, and Blissful Remedies 4 Hour Chill Slow Motion Blend due to high microbial loads contamination.... Read More
Recall: Levothyroxine and Liothyronine (Thyroid Tablets, USP)
Westminster Pharmaceuticals, LLC. issues voluntary nationwide recall of levothyroxine and liothyronine (Thyroid Tablets, USP) due to risk of adulteration.... Read More
Recall: Camber Pharmaceuticals Valsartan Tablets
Camber Pharmaceuticals, Inc. issues voluntary nationwide recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg due to detection of trace amounts of N-Nitrosodimethylamine (NDMA) impurity, found in an active pharmaceutical ingredient.... Read More
Recall: Arkon Anesthesia Delivery System
FDA issued recall of Arkon Anesthesia Delivery System due to unexpected failed state while in use or idle.... Read More
Recall: AirLife Resuscitation Devices by Vyaire Medical
FDA issued recall of AirLife Resuscitation Devices by Vyaire Medical due to manufacturing error preventing oxygen delivery.... Read More
Recall: Quest Manufacturing LLC CVS Health 12 Hour Sinus Relief Nasal Mist
Quest Manufacturing LLC issues voluntary nationwide recall of CVS Health 12 Hour Sinus Relief Nasal Mist due to microbiological contamination.... Read More
Recall: Qiagen Sciences LLC AmniSure ROM Test
FDA issued recall of Qiagen Sciences LLC AmniSure ROM Test due to lack of control line, which may lead to misinterpretation of test results.... Read More
Recall: Piperacillin and Tazobactam by AuroMedics Pharma
Voluntary nationwide recall of piperacillin and tazobactam for injection 3.375 grams per vial by AuroMedics Pharma due to presence of particulates identified as glass and silicone.... Read More
Recall: Ranier’s Rx Laboratory
Ranier’s Rx Laboratory issues voluntary recall of all sterile compounded products within expiry due to lack of sterility concerns.... Read More
Recall: King Bio
FDA issued recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids by King Bio due to microbial contamination.... Read More
Recall: valsartan
FDA issued recall of several drug products containing the active ingredient valsartan due to detection of an impurity.... Read More
Recall: Saje Splish Splash Gentle Baby Wash
FDA issued recall on Saje Splish Splash Gentle Baby Wash due to pseudomonas aeruginosa bacteria.... Read More
Recall: Monsel’s Solution by MedGyn Products
FDA issued recall on Monsel’s Solution by MedGyn Products due to possible contamination or decreased quality.... Read More
Recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105
FDA issued recall on Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 due to misinterpretation of display messages for out of range values.... Read More
Recall: Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical
FDA issued recall on Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical due potential salmonella contamination.... Read More
Recall: CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.
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
Recall: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira
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
Recall: HeartWare HVAD System by Medtronic
FDA issued recall on HeartWare HVAD system by Medtronic due to unintended intermittent electrical disconnection between the power source and the controller.... Read More
Recall: STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings
FDA issued recall on STAT-Check and Medline manual resuscitator bags by SunMed Holdings due to patient port may detach during use.... Read More
Recall: Fluticasone Propionate Nasal Spray by Apotex Corp
FDA issued recall on Fluticasone propionate nasal spray by Apotex Corp due to potential for small glass particles.... Read More
Recall: TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan
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
Recall: X-Jow and Acne Shave Products by Shadow Holdings
FDA issued recall on X-Jow and Acne Shave products by Shadow Holdings due to possible bacterial contamination.... Read More
Recall: 95% Ethyl Alcohol Product by Ethanol Extraction
FDA issued recall on 95% ethyl alcohol product by Ethanol Extraction due to a possible contamination with methanol.... Read More
Recall: HeartMate 3™ Left Ventricular Assist System
FDA issued recall on HeartMate 3™ Left Ventricular Assist System due to potential malfunction that may lead to graft occlusion.... Read More
Recall: Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing
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
Recall: 7K and Poseidon 4500 by Shoreside Enterprises
FDA issued recall on 7K and Poseidon 4500 by Shoreside Enterprises due to presence of undeclared sildenafil and/or tadalafil.... Read More
Recall: MindFrame Capture LP Revascularization Device by Medtronic
FDA issued recall on MindFrame Capture LP Revascularization Device by Medtronic due to wire material that may break or separate during use.... Read More
Recall: Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical
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
Recall: Fabius Anesthesia Machines by Dräger Medical
FDA issued recall on Fabius Anesthesia Machines by Dräger Medical due to production step error.... Read More
Recall: Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma
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
Recall: Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma
FDA issued recall on piperacillin and tazobactam for injection, USP 3.375 g vials by AuroMedics Pharma due to particulate matter.... Read More
Recall: NxtGen Botanicals Maeng Da Kratom by NGB Corp.
FDA issued recall on NxtGen Botanicals Maeng Da Kratom by NGB Corp. due to possible salmonella contamination.... Read More
Recall: Certain Kratom-Containing Powder Products by Viable Solutions
FDA issued recall on certain kratom-containing powder products by Viable Solutions due to possible salmonella contamination.... Read More
Recall: All Products Marketed as Sterile by Coastal Meds
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
Recall: Acrodose PLus and PL Systems by Haemonetics
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
Recall: Sterile Injectable Products by Premier Pharmacy Labs
FDA issued recall on sterile injectable products by Premier Pharmacy Labs due to lack of sterility assurance.... Read More
Recall: Maeng Da Red Powder and Capsules by Club 13
FDA issued recall on Maeng Da Red powder and capsules by Club 13 due to possible contamination with salmonella.... Read More
Recall: Kratom-containing Products by Triangle Pharmanaturals
FDA issued recall on kratom-containing products by Triangle Pharmanaturals due to risk of salmonella.... Read More
Recall: Dietary Supplements by Nutrizone
FDA issued recall on Dietary supplements by Nutrizone due to potential for salmonella contamination.... Read More
Recall: Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA
FDA issued recall on Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA due to possible potential contamination.... Read More
Recall: Eclipse Kratom by Tamarack
FDA issued recall on Eclipse Kratom by Tamarack due to possible salmonella contamination.... Read More
Recall: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD)
FDA issued recall on BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD) due to chemical interference with certain tests.... Read More
Recall: NeuroBlate Probe by Monteris Medical
FDA issued recall on NeuroBlate Probe by Monteris Medical due to unintended heating.... Read More
Recall: Alka-Seltzer Plus Products
FDA issued recall on Alka-Seltzer Plus products because ingredients on front sticker may not match product in carton.... Read More
Recall: Kratom-containing Powder Products by PDX Aromatics
FDA issued recall on kratom-containing powder products by PDX Aromatics due to potential for contamination with salmonella.... Read More
Recall: Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals
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
Recall: Hydromorphone HCL Injection USP by Hospira
FDA issued recall on hydromorphone hcl injection USP by Hospira due to potential for empty or cracked glass vials.... Read More
Recall: Bella Diet Capsules by Bella All Natural
FDA issued recall on Bella Diet Capsules by Bella All Natural due to presence of sibutramine.... Read More
Recall: Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic
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
Recall: Labetalol Hydrochloride Injection by Hospira
FDA issued recall on labetalol hydrochloride Injection by Hospira due to potential for cracked glass at rim surface of vials.... Read More
Recall: Acyclovir 400mg Tablets by Apace Packaging
FDA issued recall on Acyclovir 400 mg Tablets by Apace Packaging due to product mix-up.... Read More
Recall: HeartStart MRx Defibrillator by Philips Electronics
FDA issued recall on HeartStart MRx Defibrillator by Philips Electronics because defects in gas discharge tubes may cause device failure.... Read More
Recall: Gericare Eye Wash by Kareway Products
FDA issued recall on Gericare Eye Wash by Kareway Products due to potential product contamination.... Read More
Recall: AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical
FDA issued recall on AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical due to manufacturing error.... Read More
Recall: Multiple Drug Products by Flawless Beauty
FDA issued recall on multiple drug products by Flawless Beauty because they are misbranded or unapproved.... Read More
Recall: Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories
FDA issued recall on Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories due mislabeling.... Read More
Recall: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics
FDA issued recall on Levofloxacin in 5 percent dextrose 250mg/50mL by AuroMedics due to presence of visible particulate matter.... Read More
Recall: Certitude Delivery System by Edwards Lifesciences
FDA issued recall on Certitude Delivery System by Edwards Lifesciences due to mold overflow defect which may obstruct blood flow.... Read More
Recall: Clopidogrel Tablets USP, 75 mg by International Laboratories
FDA issued recall on Clopidogrel tablets USP, 75 mg by International Laboratories due to product mislabeling.... Read More
Recall: Compounded Sterile Products by PharMEDium Services
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
Recall: Compounded Sterile Products by PharMEDium Services
FDA issued recall on compounded sterile products by PharMEDium Services due to lack of sterility assurance.... Read More
Recall: Reprocessed Agilis Steerable Introducer Sheath by Sterilmed
FDA issued recall on reprocessed Agilis Steerable introducer sheath by Sterilmed due to improper seal of sheath hub.... Read More
Recall: Linezolid Injection 600mg/300mL flexible bags
FDA issued recall on linezolid injection 600mg/300mL flexible bags due to presence white particle matter that has been identified as mold.... Read More
Recall: Pantoprazole Sodium for Injection 40 Mg Per Vial
FDA issued recall on pantoprazole sodium for injection 40mg per vial for presence of glass particles.... Read More
Recall: Defibrillation Electrodes for Lifepak AEDs by Physio-Control
FDA issued recall on defibrillation electrodes for Lifepak AEDs by Physio-Control for incorrect placement instructions for infants depicted on artwork.... Read More
Recall: Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics
FDA issued recall on Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics for lack of sterility assurance and other quality issues.... Read More
Recall: Riomet (Metformin Hydrochloride Oral Solution)
FDA issued recall on Riomet (Metformin Hydrochloride Oral Solution) for microbial contamination.... Read More
Recall: Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone
FDA issued recall on Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone for possible sub potent and super potent tablets.... Read More
Recall: Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection
FDA issued recall on Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection for presence of particulate matter.... Read More
Recall: Ridge Properties DBA Pain Relief Naturally Products
FDA issued recall on Ridge Properties DBA Pain Relief Naturally Products for manufacturing concerns.... Read More
Recall: Midazolam Injection, USP, 2 mg/2 mL mL by Fresenius Kabi
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
Voluntary Market Withdrawal: Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]
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
Recall: Injectable Products by SCA Pharmaceuticals
FDA issued recall on injectable products by SCA Pharmaceuticals for potential contamination.... Read More
Recall: Intralipid 20% IV Fat Emulsion by Baxter
FDA issued recall on Intralipid 20% IV Fat Emulsion by Baxter because one shipment of product exposed to subfreezing temperatures.... Read More
Recall: Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics
FDA issued recall on Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics for risk of blocked guidewire lumen preventing balloon utilization.... Read More
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
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