Safety Alerts and Recalls

Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated to reduce the risk of stroke and blood clots.

Yet another infant formula maker has recalled some of its product over concerns of contamination with Cronobacter sakazakii bacteria.

In immunocompromised individuals, the use of contaminated product could potentially lead to life-threatening infections.

Pluvicto is indicated for patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.

The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.

The Trifecta and Trifecta GT valves are heart valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves.

Brimonidine Tartrate Ophthalmic Solution is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

While not approved for human use, xylazine has been detected in combination with opioids (eg, illicit fentanyl), and with stimulants (eg, methamphetamine, cocaine).

To assess the potential risk, the FDA is working with manufacturers of neonatal incubators and evaluating data from their products.

Earlier this month, Global Pharma Healthcare had announced a nationwide recall of its artificial tear lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma.