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December 05, 2017 at 10:00 AM
The use of impacted alcohol prep pads could result in adverse events such as infections.
December 05, 2017 at 7:30 AM
UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
December 01, 2017 at 8:30 AM
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
December 01, 2017 at 8:10 AM
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
November 28, 2017 at 9:00 AM
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.
November 27, 2017 at 10:10 AM
Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.
November 21, 2017 at 12:00 AM
Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. Posted 11/21/2017
November 17, 2017 at 12:00 AM
The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. Posted 11/17/2017
November 15, 2017 at 1:20 PM
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
November 15, 2017 at 11:00 AM
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
November 14, 2017 at 10:00 AM
Silicone, when injected into areas with many blood vessels, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
November 08, 2017 at 3:00 PM
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
November 06, 2017 at 8:30 AM
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
November 06, 2017 at 8:00 AM
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
October 23, 2017 at 8:00 AM
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
October 21, 2017 at 12:00 AM
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
October 19, 2017 at 3:30 PM
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
October 07, 2017 at 12:00 AM
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
October 06, 2017 at 11:00 AM
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
October 03, 2017 at 3:00 PM
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
October 03, 2017 at 10:00 AM
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.
September 28, 2017 at 11:00 AM
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
September 26, 2017 at 7:00 AM
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
September 25, 2017 at 6:30 PM
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
September 25, 2017 at 1:30 PM
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.