Safety Alerts and Recalls

Safety Alerts & Recalls

FDA Wants More Studies on Real-World Duoenoscope Cleaning

The Food and Drug Administration (FDA) has ordered the three manufacturers of duodenoscopes marketed in the United States to conduct postmarket surveillance studies for greater understanding of how the devices are reprocessed in real-world settings.

Nasal Allergy Spray Currently Unavailable

Merck has issued a letter to healthcare professionals letting them know that Nasonex (mometasone furoate monohydrate) Nasal Spray 50mcg is currently out of stock due to a manufacturing issue.

Sibutramine Detected in Two OTC Supplements

The Food and Drug Administration (FDA) is advising consumers not to purchase or use two dietary supplements promoted and sold for weight loss due to the presence of undeclared sibutramine.

Which Drugs Can Up the Risk of Photosensitivity?

The Food and Drug Administration (FDA) is recommending that clinicians discuss with their patients the potential for some medicines to cause photosensitivity that can lead to sunburn-like symptoms, a rash, or other unwanted side effects.

Two Banned Ingredients Detected in Weight Loss Caps

Lucy's Weight Loss System announced a voluntary recall of all lots of Pink Bikini and Shorts on the Beach Blue and Gold Edition capsules to the consumer level.

Two HCV Drugs to Be Discontinued

The Food and Drug Administration (FDA) announced that Rebetol (ribavirin; Merck) capsules and PegIntron (peginterferon alfa-2b; Merck) for Injection are being discontinued.

Fresenius Kabi Discontinues Two Injectables

The Food and Drug Administration (FDA) announced that two injectable products by Fresenius Kabi USA have been discontinued.

FDA Warns of Possible Dosing Error for Combo Antibiotic

The FDA is warning healthcare professionals about possible dosing errors with Avycaz (ceftazidime and avibactam; Actavis) injection due to confusion about the drug strength shown on the vial and carton labels.

New Contraindication for PDE-5 Inhibitors

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for phosphodiesterase 5 (PDE-5) inhibitors regarding a new contraindication with guanylate cyclase stimulators, such as riociguat.

Bystolic Tabs Still on Backorder

The Food and Drug Administration (FDA) reported that Bystolic (nebivolol; Forest) tablets are currently in shortage.