Safety Alerts & Recalls
The Food and Drug Administration (FDA) has issued a list of supplemental duodenoscope reprocessing measures to further reduce the risk of infection and increase the safety of these medical devices.
The Food and Drug Administration (FDA) confirmed that a case of definite progressive multifocal leukoencephalopathy (PML) and probable PML have been reported in patients taking Gilenya (fingolimod; Novartis) for multiple sclerosis.
Purdue Pharma announced the discontinuance of Dilaudid-HP (hydromorphone HCl) Injection 50mL single dose vials and Dilaudid-HP Injection Sterile Lyophilized Powder 250mg vials.
Unichem Pharmaceuticals issued a voluntary nationwide recall of Hydrochlorothiazide 25mg tablets after the discovery of a Clopidogrel tablet in a bottle.
The Food and Drug Administration (FDA) announced modifications to the Tanzeum (albiglutide [recombinant fusion protein]; GlaxoSmithKline) and Trulicity (dulaglutide; Eli Lilly) Approved Risk Evaluation and Mitigation Strategies (REMS) program following the safety labeling changes that were approved in March 2015.
The Food and Drug Administration (FDA) announced changes to the Kynamro (mipomersen sodium; Genzyme) Approved Risk Evaluation and Mitigation Strategies (REMS) program.
The Food and Drug Administration (FDA) is warning healthcare providers and patients that the name confusion between Brintellix (vortioxetine; Takeda and Lundbeck) and Brilinta (ticagrelor; AstraZeneca) has led to the wrong medication being prescribed or dispensed.
ChiRhoClin announced that the shortage of ChiRhoStim (human secretin for injection) has been resolved, after the company worked with the Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER), the Drug Shortage Team, and the Office of Pharmaceutical Quality (OPQ) to resolve the shortage.
The Food and Drug Administration (FDA) is investigating the safety risk associated with repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
Teva announced a voluntary recall of 6 lots of Adrucil (fluorouracil injection) 5g/100mL (50mg/mL) due to potential particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.