Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration
Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling. (Source: FDA MedWatch)
Source: FDA MedWatch - June 16, 2015 Category: American Health Source Type: news
Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface
Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015 (Source: FDA MedWatch)
Source: FDA MedWatch - June 3, 2015 Category: American Health Source Type: news
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures. (Source: FDA MedWatch)
Source: FDA MedWatch - May 28, 2015 Category: American Health Source Type: news
Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer
Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating. (Source: FDA MedWatch)
Source: FDA MedWatch - May 27, 2015 Category: American Health Source Type: news
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors
Can lead to to administration of more drug than was prescribed. (Source: FDA MedWatch)
Source: FDA MedWatch - May 20, 2015 Category: American Health Source Type: news
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 (Source: FDA MedWatch)
Source: FDA MedWatch - May 15, 2015 Category: American Health Source Type: news
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. (Source: FDA MedWatch)
Source: FDA MedWatch - May 13, 2015 Category: American Health Source Type: news
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue
Possibility of a tear on the left atrial wall during use of the device. (Source: FDA MedWatch)
Source: FDA MedWatch - May 7, 2015 Category: American Health Source Type: news
Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter
Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected. (Source: FDA MedWatch)
Source: FDA MedWatch - May 5, 2015 Category: American Health Source Type: news
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems
Patients may need a repeat mammogram or additional medical follow-up. (Source: FDA MedWatch)
Source: FDA MedWatch - April 30, 2015 Category: American Health Source Type: news
Injectable Products by Mylan: Recall - Presence of Particulate Matter
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. (Source: FDA MedWatch)
Source: FDA MedWatch - April 24, 2015 Category: American Health Source Type: news
Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. (Source: FDA MedWatch)
Source: FDA MedWatch - April 24, 2015 Category: American Health Source Type: news
Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing
The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015 (Source: FDA MedWatch)
Source: FDA MedWatch - April 23, 2015 Category: American Health Source Type: news
Mucinex Fast-MAX Products: Recall - Incorrect Labeling
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. (Source: FDA MedWatch)
Source: FDA MedWatch - April 22, 2015 Category: American Health Source Type: news
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died. (Source: FDA MedWatch)
Source: FDA MedWatch - April 17, 2015 Category: American Health Source Type: news
