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FDA MEDICAL ALERTS
CURRENT HEADLINES

Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
UPDATED 07/22/2014. Recall classified as Class I. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could lead to serious health consequences, including death.

Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging
Failure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.

Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death

Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter
If infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.

Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance
UPDATED 07/23/2014. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
Voluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.

Weight Loss Products: Public Notification - Undeclared Drug Ingredients
May present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke. May interact, in life-threatening ways, with other medications.

Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury
The use of affected product may cause serious adverse health consequences, including death.

Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury
Device failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death.

Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization.

Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved
All lots of non-expired products being recalled.

Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
Too much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart.

HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage
Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.

Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions
Reactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.

Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
Recommendations for use remain the same; label updates required.

Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin
Use could result in serious muscle injury, particularly if taking with prescription “statins”; patients with pre-existing liver disease may be at an increased risk for liver injury.

Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems
Patients who had a mammogram performed at Big Sky Diagnostic Imaging should speak to their health care providers about whether their mammograms need to be repeated.

Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
Warning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing
Reports of 12 serious injuries and one death.

Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
Docetaxel contains alcohol, which affects the central nervous system.