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FDA MedWatch Safety Alerts
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors
Can lead to administration of more drug than was prescribed.
Posted: May 20, 2015, 10:00 pm
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
Posted: May 15, 2015, 3:00 pm
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
UPDATED 05/15/2015. Testosterone product labels updated.
Posted: May 15, 2015, 2:50 pm
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
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
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue
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
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems
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
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
Posted: April 17, 2015, 4:15 pm
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub
Separation could result in required intervention to prevent permanent impairment or damage.
Posted: April 16, 2015, 1:00 pm
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter
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
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
UPDATED 04/08/2015. Wallcur Practi-IV solutions bags are recalled.
Posted: April 8, 2015, 6:30 pm
Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance
Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Posted: April 2, 2015, 3:45 pm
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
Risk of potentially life-threatening allergic reactions.
Posted: March 31, 2015, 11:00 am
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
If not properly reprocessed patients may be exposed to serious infections.
Posted: March 26, 2015, 7:00 pm
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems
The facility may not perform mammography due to the revocation of its accreditation.
Posted: March 24, 2015, 7:10 pm
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone
Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
Posted: March 24, 2015, 4:50 pm