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FDA MEDICAL ALERTS
CURRENT HEADLINES

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch
Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.

Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients
Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke

Intravia Containers by Baxter: Recall - Particulate Matter
UPDATED 11/20/2014. Recall Classified as Class I. Particles may irritate patient’s veins, cause pain, worsen a previous infection, cause allergic reactions, block blood vessels, and cause death.

Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur
Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death.

ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection
The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.

Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death
FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination
There is the possibility of fungal infection should patients come in contact with the mold.

Mayhem: Public Notification - Undeclared Drug Ingredients
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems.

Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator
Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.

GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity
Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.

V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient
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.

10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.

Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.

Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria
Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.

Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.

Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

September 2014
September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.

LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage
A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.

Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units
The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.