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. (Source: FDA MedWatch)
Source: FDA MedWatch - April 16, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - April 10, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - April 2, 2015 Category: American Health Source Type: news
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
Risk of potentially life-threatening allergic reactions. (Source: FDA MedWatch)
Source: FDA MedWatch - March 31, 2015 Category: American Health Source Type: news
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
If not properly reprocessed patients may be exposed to serious infections. (Source: FDA MedWatch)
Source: FDA MedWatch - March 26, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - March 24, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - March 24, 2015 Category: American Health Source Type: news
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug
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. (Source: FDA MedWatch)
Source: FDA MedWatch - March 23, 2015 Category: American Health Source Type: news
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks
If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks. (Source: FDA MedWatch)
Source: FDA MedWatch - March 19, 2015 Category: American Health Source Type: news
Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination
Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result. (Source: FDA MedWatch)
Source: FDA MedWatch - March 12, 2015 Category: American Health Source Type: news
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene
Can lead to device failure, possible product contamination, and potential serious adverse health consequences. (Source: FDA MedWatch)
Source: FDA MedWatch - March 11, 2015 Category: American Health Source Type: news
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction
Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015 (Source: FDA MedWatch)
Source: FDA MedWatch - March 9, 2015 Category: American Health Source Type: news
Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling
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. (Source: FDA MedWatch)
Source: FDA MedWatch - March 6, 2015 Category: American Health Source Type: news
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure
Risk of injury or death resulting from prolonged interruption in therapy. (Source: FDA MedWatch)
Source: FDA MedWatch - March 6, 2015 Category: American Health Source Type: news
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response. (Source: FDA MedWatch)
Source: FDA MedWatch - March 6, 2015 Category: American Health Source Type: news
