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FDA 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.
Posted: January 18, 2018, 7:00 pm
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 when needed.
Posted: January 17, 2018, 2:40 pm
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; back pain or chest pain; hypotension or shock.
Posted: January 16, 2018, 3:40 pm
CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.
Posted: January 12, 2018, 9:20 pm
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.
Posted: January 12, 2018, 6:30 pm
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, cardiac, limb, renal, or gastrointestinal injury may result.
Posted: January 11, 2018, 4:30 pm
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.
Posted: January 11, 2018, 1:00 pm
Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.
Posted: January 11, 2018, 12:00 am
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 clotting in blood vessels, which may be life-threatening.
Posted: January 4, 2018, 1:10 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: January 2, 2018, 7:30 pm
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 system (air embolism).
Posted: January 2, 2018, 5:00 pm
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.
Posted: December 26, 2017, 2:00 pm
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 treatment with ICS alone.
Posted: December 20, 2017, 11:00 pm
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 clotting in blood vessels, which may be life-threatening.
Posted: December 20, 2017, 12:30 pm
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.
Posted: December 19, 2017, 8:30 pm
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.
Posted: December 19, 2017, 1:00 pm
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: December 14, 2017, 1:00 pm
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.
Posted: December 5, 2017, 3:00 pm
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.
Posted: December 5, 2017, 12:30 pm
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
Posted: December 1, 2017, 1:30 pm