Skip to main content
 

2017

Top
  • Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

    Monday, December 4, 2017
    During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes. CSL Behring is taking no action with products on the...

    Read More
  • The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

    Wednesday, November 29, 2017
    The 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, 2017
    Sun 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, 2017
    The 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, 2017
    Update 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, 2017
    Baxter 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, 2017
    FDA 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, 2017
    Fresenius 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
  • Advice for Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas, Including Puerto Rico and US Virgin Islands

    Wednesday, October 25, 2017
    The purpose of this HAN advisory is to remind clinicians assessing patients currently in or recently returned from hurricane-affected areas to be vigilant in looking for certain infectious diseases, including leptospirosis, dengue, hepatitis A, typhoid fever, vibriosis, and influenza. Additionally,...

    Read More
  • Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

    Monday, October 23, 2017
    ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.

    Read More