News

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of

Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling– 1.27.21

 

Midwestern Pet Foods Voluntarily Expands Recall of Pet Food for Aflatoxin

Health Risk– 1/15/21

 

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine

Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination– 1/4/21

 

Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex®

Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial

Contamination– 12/29/20

 

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral

Rinse USP, 0.12% Due to Microbial Contamination-11/9/20

 

Recommendations on Providing Clear Instructions to Patients Who Self-Collect

an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2

Testing – Letter to Health Care Providers-10/14/20

 

Mammography Problems at Allison Breast Center at Monument Radiology in

Richmond, Virginia: FDA Safety Communication– 9/25/20

 

Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol-9/1/20

 

Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Due to Potential Presence of Undeclared Methanol–8/18/20

 

FDA Updates on Hand Sanitizers with Methanol-7/28/20

 

Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert – FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing– 7/23/20

 

Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval-5/21/20

 

Summitt Labs Issues Voluntary Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results-5/15/20

 

MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug-5/12/20

 

Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers-5/8/20

 

Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use– 5/1/20

 

Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication – FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems-4/24/20

 

MedWatch Online Voluntary Reporting Form-4/21/20

 

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples-4/21/20

 

Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753-4/21/20

 

Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers-4/21/20

 

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA-4/17/20

 

International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A-4/17/20

 

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications-4/17/20

 

Fecal Microbiota for Transplantation: New Safety Information – Regarding Additional Protections for Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2-4/10/20

 

Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment– 4/7/20

 

LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue-4/3/20

 

All Ranitidine Products (Zantac): Press Release – FDA Requests Removal-4/1/20

 

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture-3/30/20

 

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion-3/30/20

 

FDA Letter to Stakeholders: Do Not Use Chloroquine Phosphate Intended for Fish as Treatment for COVID-19 in Humans-3/28/20

 

Dr. Reddy’s Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening-3/27/20

 

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments-3/25/20

FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration-3/24/20

 

Fecal Microbiota for Transplantation: Safety Alert – Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19-3/24/20

 

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion-3/18/20

 

Natural Remedy Store Issues Voluntary Worldwide – Recall of Active Male Due to Presence of Undeclared Tadalafil-3/17/20

 

Fecal Microbiota for Transplantation: Safety Alert – Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms-3/12/20

 

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors-3/6/20

 

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates-3/5/20

 

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning – Due to Restricting Use for Allergic Rhinitis-3/4/20

 

SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication-3/3/20

 

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity-2/27/20

 

Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles-2/25/20

 

Med Man Expands Voluntary Nationwide Recall of Up2 and Bow & Arrow Due to Presence of Undeclared Sildenafil-2/24/20

 

Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters-2/24/20

 

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing-2/21/20

 

Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway-2/20/20

 

Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate– 2/20/20

 

ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure-2/19/20

 

Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug-2/13/20

 

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing-2/12/20

 

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation-2/7/20

 

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values-2/4/20

 

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination– 2/3/20

 

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk- 1/31/20

 

Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve– 1/29/20

 

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication – FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems– 1/28/20

 

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2– 1/24/20

 

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication– 1/23/20

 

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products– 1/23/20

 

 

 

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility– 1/21/20

 

 

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication– 1/17/20

 

 

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility– 1/17/20

 

 

Statement on quality issues with certain Cardinal Health surgical gowns and packs– 1/16/20

 

 

Statement on quality issues with certain Cardinal Health surgical gowns and packs– 1/17/20

 

 

Belviq, Belviq XR (lorcaserin): Drug Safety Communication – Due to Possible Increased Risk of Cancer– 1/14/20

 

 

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles– 1/10/20

 

 

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator-1/10/20

 

 

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity– 1/9/20

 

 

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited– 1/9/20

 

 

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)– 1/8/20

 

 

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength– 12/31

 

 

Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination– 12/26/19

 

 

LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error– 12/20/19

 

 

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination– 12/20/19

 

 

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)– 12/19/19

 

 

Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity- 12/18/19

 

 

GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall– 12/17/19

 

 

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall– 12/17/19

 

 

Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause  Buckling- 12/17/19

 

 

Recalled Basic Reset and Biogenyx products including drugs, dietary supplements and devices-12/10/19

 

 

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products– 12/10/19

 

 

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing– 11/27/19

 

 

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)– 11/18/19

 

 

Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks– 11/5/19

 

 

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance– 10/28/19

 

 

Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.– 10/23/19

 

 

Sterile Injectables by Viatrexx Bio: Recall – Due to a Lack of Sterility Assurance– 10/16/19

 

 

All Sterile Compounded Drug Products by Innoveix Pharmaceuticals: Recall – Due to a Lack of Sterility Assurance– 10/11/19

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