Skip to main content
 

August 2017

Top
  • Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

    Thursday, August 31, 2017
    Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with...

    Read More
  • Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter

    Thursday, August 31, 2017
    Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.

    Read More
  • Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

    Tuesday, August 29, 2017
    On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers.

    Read More
  • Texas Board of Nursing (BON) to Implement Disaster Licensing Procedure

    Tuesday, August 29, 2017
    The Texas BON is implementing a disaster licensing procedure to respond to this declared disaster.

    Read More
  • ESRD Network of Texas Disaster Updates

    Sunday, August 27, 2017
    ESRD Network of Texas maintains a comprehensive list of resources and materials on their website. The Network also actively participates in the Texas ESRD Emergency Coalition (TEEC).

    Read More
  • Harvey: A Life Threatening Hurricane

    Friday, August 25, 2017
    Hurricane Harvey is a life-threatening and rapidly intensifying storm that is expected to make landfall on the Texas Gulf Coast with devastating rainfall flooding, dangerous storm surge flooding, and destructive winds.

    Read More
  • Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

    Monday, August 21, 2017
    Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

    Read More
  • Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

    Wednesday, August 16, 2017
    Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.

    Read More
  • Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

    Friday, August 11, 2017
    International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg...

    Read More
  • Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

    Thursday, August 10, 2017
    FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on...

    Read More