AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown
Ventilator shutdown may cause serious adverse health consequences, including death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 28, 2016 Category: American Health Source Type: alerts
Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 26, 2016 Category: American Health Source Type: alerts
HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 22, 2016 Category: American Health Source Type: alerts
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 22, 2016 Category: American Health Source Type: alerts
WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
Reports of hair loss, hair breakage, balding, itching, and rash. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 19, 2016 Category: American Health Source Type: alerts
Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 16, 2016 Category: American Health Source Type: alerts
INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 12, 2016 Category: American Health Source Type: alerts
Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 5, 2016 Category: American Health Source Type: alerts
HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion
Batteries may lose power prematurely due to faulty cells. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 29, 2016 Category: American Health Source Type: alerts
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 14, 2016 Category: American Health Source Type: alerts
Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 8, 2016 Category: American Health Source Type: alerts
Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 7, 2016 Category: American Health Source Type: alerts
Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 7, 2016 Category: American Health Source Type: alerts
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 6, 2016 Category: American Health Source Type: alerts
Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars
Reports of severe redness, pain, skin discoloration, blistering, and cracked skin. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 2, 2016 Category: American Health Source Type: alerts
