MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
Posted: May 28, 2015, 3:10 pm
Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
Posted: May 27, 2015, 5:00 pm
Can lead to administration of more drug than was prescribed.
Posted: May 20, 2015, 10:00 pm
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
Posted: May 15, 2015, 3:00 pm
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.
Posted: May 13, 2015, 4:00 am
Possibility of a tear on the left atrial wall during use of the device.
Posted: May 7, 2015, 4:50 pm
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.
Posted: May 5, 2015, 12:20 pm
Patients may need a repeat mammogram or additional medical follow-up.
Posted: April 30, 2015, 6:30 pm
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Posted: April 24, 2015, 6:45 pm
Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.
Posted: April 24, 2015, 2:00 pm
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
Posted: April 23, 2015, 4:00 am
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Posted: April 22, 2015, 7:10 pm
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
Posted: April 17, 2015, 4:15 pm
Separation could result in required intervention to prevent permanent impairment or damage.
Posted: April 16, 2015, 1:00 pm
Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Posted: April 10, 2015, 2:40 pm
UPDATED 04/08/2015. Wallcur Practi-IV solutions bags are recalled.
Posted: April 8, 2015, 6:30 pm
Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Posted: April 2, 2015, 3:45 pm
Risk of potentially life-threatening allergic reactions.
Posted: March 31, 2015, 11:00 am
If not properly reprocessed patients may be exposed to serious infections.
Posted: March 26, 2015, 7:00 pm