Safety Alerts & Recalls
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.
Life & More LLC announced a voluntary recall of 783 bottles of Akttive High Performance Fat Burner Gold capsules marketed as weight loss supplements.
The Food and Drug Administration (FDA) is warning that black henna tattoos may cause harmful skin reactions in some people.
Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride intravenous (IV) solutions due to potential particulate matter.
The Food and Drug Administration (FDA) announced changes to the Tikosyn (dofetilide; Pfizer) Risk Evaluation and Mitigation Strategies (REMS) program.
The Food and Drug Administration (FDA) has issued a warning that pulmonary hypertension has been reported in infants and newborns treated with Proglycem (diazoxide; Teva) for low blood glucose.
The Food and Drug Administration (FDA) issued a reminder to quarantine and discontinue distribution of all affected lots of Mylan's Calcium Chloride Intravenous Infusion 10% w/v.
The Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack or stroke.
An alert has been issued by the American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) on the use of dosage cups that measure liquid medications after several medication error events have been reported.