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The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
Wednesday, November 29, 2017The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Read More -
Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
Tuesday, November 28, 2017Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The... Read More -
FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel
Monday, November 27, 2017The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. Read More -
FDA Statement: Impact of IV Fluid Shortages Following Hurricane Destruction
Monday, November 20, 2017Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage Read More -
Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter
Thursday, November 16, 2017Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 8/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of... Read More -
Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
Thursday, November 16, 2017FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety... Read More -
Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall
Monday, November 6, 2017Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection,... Read More
November 2017
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