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FDA MEDICAL ALERTS
CURRENT HEADLINES

DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery
Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.

CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft
UPDATED 08/27/2014. Lot numbers added.

Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility
Potential adhesion defect which may lead to infection.

Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold
Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.

Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use
Fragments of the sheath could possibly block blood vessels.

Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter
Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination
Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.

Arize: Public Notification - Undeclared Drug Ingredient
Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter
Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.

White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles
Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.

RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.

Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter
The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli.

Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler
Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates
Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.

GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury
Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.

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.