News

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

November 17, 2017

Summary: Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage

CDC Health Alert: Advice for Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas, Including Puerto Rico and US Virgin Islands

October 24, 2017

St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion – Update

October 19, 2017

Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette

The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit.

Activase (Alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

Issue: Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level.

FDA Safety Communication: FDA recommends separating dosing of Kayexalate (sodium polystyrene sulfonate) from all other oral drugs

The FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as any other medicines taken by mouth.

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

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.

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

Based on data from two recently halted clinical trials, the U.S.

FDA Safety Communication: Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's Implantable Cardiac Pacemakers

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 cert

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

August 18, 2017

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