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FDA MEDICAL ALERTS
CURRENT HEADLINES

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.

Sit and Slim II: Public Notification - Hidden Drug Ingredients
FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.

ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended
Use of the affected product may cause serious adverse health consequences, including death.

CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure
Ventilator shut-off from power failures may lead to serious patient injury or death.

Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance
Patients in Oregon and Washington may be at risk of serious infections which may be life threatening.

Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
One lot may have experienced temperature excursions during shipment.

SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure
Product failure could cause a potential delay in controlling axilla hemorrhage.

Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break
Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.

Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling
The labeled expiration date is longer than the known stability of the product.

Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.

Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
FDA approves label changes after review of a five year safety study.

Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock
UPDATED 09/16/2014. One AC/DC power adapter production lot added to recall. The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter
Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.

Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance
UPDATED 09/09/2014. FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired.