Can lead to to administration of more drug than was prescribed.
5/20/2015 10:00:00 PM
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
5/15/2015 3:00:00 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.
5/13/2015 4:00:00 AM
Possibility of a tear on the left atrial wall during use of the device.
5/7/2015 4:50:00 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.
5/5/2015 12:20:00 PM
Patients may need a repeat mammogram or additional medical follow-up.
4/30/2015 6:30:00 PM
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
4/24/2015 6:45:00 PM
Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.
4/24/2015 2:00:00 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
4/23/2015 4:00:00 AM
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
4/22/2015 7:10:00 PM
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
4/17/2015 4:15:00 PM
Separation could result in required intervention to prevent permanent impairment or damage.
4/16/2015 1:00:00 PM
Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
4/10/2015 2:40:00 PM
Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
4/2/2015 3:45:00 PM
Risk of potentially life-threatening allergic reactions.
3/31/2015 11:00:00 AM
If not properly reprocessed patients may be exposed to serious infections.
3/26/2015 7:00:00 PM
The facility may not perform mammography due to the revocation of its accreditation.
3/24/2015 7:10:00 PM
Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
3/24/2015 4:50:00 PM
FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
3/23/2015 6:00:00 PM
If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
3/19/2015 4:00:00 PM
Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
3/12/2015 11:30:00 AM
Can lead to device failure, possible product contamination, and potential serious adverse health consequences.
3/11/2015 12:30:00 AM
Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
3/9/2015 10:00:00 PM
Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
3/6/2015 7:10:00 PM
Risk of injury or death resulting from prolonged interruption in therapy.
3/6/2015 3:30:00 PM