Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
UPDATED 03/16/2017. Glutamine in United Pharmacy’s compounded GAC 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018
Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.
Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
Prescribers advised to consider using other antibiotics in patients with heart disease.
Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated.
Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.
FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.
Probability of a potentially sight threatening eye infection or impairment.
FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.