MedWatch Safety Alerts

Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter

Use of a non-sterile injectable product could result in fatal infections

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure

Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy

Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement

Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced

General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products

Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening

Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and

Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening

Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub

Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory

Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold

Use of a non-sterile injectable product could result in fatal infections in a broad array of patients

Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed

FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than

Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles

Administration of a glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and

Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork

Incorrect placement of electrodes on an infant may result in failure to deliver an effective shock. A delay in therapy could result in serious injury and/or death

Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

Trace amounts of gadolinium may stay in the body long-term

Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient

Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels

Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

The use of impacted alcohol prep pads could result in adverse events such as infections

Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis

Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label

General Information