Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
Innoveix Pharmaceuticals, Inc. announced on October 10, 2019 that it is voluntarily recalling all sterile compounded drug products, within expiry, because of a lack of assurance of sterility.
Recalled products include injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2, which were distributed to customers and healthcare facilities. The recall was initiated after an FDA inspection was conducted at the facility.
While the company states the recall is out of “an abundance of caution” and it has not received any notice of adverse events, use of product that is intended to be sterile but is not sterile may result in serious and life-threatening infections. The company is advising customers to stop use of the products and to return any product they may have for a full refund. Adverse events may be reported to FDA through the agency’s MedWatch program.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.