Safety Alerts and Recalls

Safety Alerts & Recalls

FDA Warns Against Unapproved Prescription Ear Drops

As part of the Unapproved Drugs Initiatives, the Food and Drug Administration (FDA) announced it will take enforcement action against companies that manufacture and/or distribute unapproved prescription otic products labeled to relieve ear pain, infection, and inflammation.

Safety of Codeine Products for Cough, Cold in Children Under Investigation

The Food and Drug Administration (FDA) is evaluating the safety of using codeine-containing products to treat cough and cold in children under the age of 18 due to the potential for serious adverse reactions such as slow or difficult breathing.

Kaletra Label Gets Updated Drug Interaction, Pediatric Use

The Food and Drug Administration (FDA) announced that the product label for Kaletra (lopinavir/ritonavir; AbbVie) has been updated to include drug interaction information and to update the Specific Populations, Pediatric Use subsection.

FDA: Antiemetic Shortage Announced

The Food and Drug Administration (FDA) announced that Emend (aprepitant; Merck) is currently in shortage.

FDA: Derm Dilemma with Daytrana

The Food and Drug Administration (FDA) has issued a warning that the use of Daytrana patch (methylphenidate transdermal system; Noven) may result in permanent loss of skin color.

Black Box Warning for Potiga Reviewed Again by FDA

The Food and Drug Administration (FDA) has determined that the Boxed Warning for Potiga (ezogabine; GlaxoSmithKline) is adequate to manage the potential risks of vision loss due to pigment changes in the retina and skin discoloration.

Mylan Expands Recall of Multiple Injectable Products

Mylan announced that it is expanding a voluntary recall of multiple injectable products to the hospital/user level due to the presence of visible foreign particulate matter.

NSAID, Antihistamine Discovered in Joint Pain Supplement

The Food and Drug Administration (FDA) has warning consumers to not buy or use GC Natural's Pyrola Advanced Joint Formula, an herbal supplement marketed for joint pain.

Weight Loss Supplement Recalled Due to Multiple Hidden Ingredients

The Food and Drug Administation (FDA) announced that SmartLip360 is voluntarily recalling 122 lots of Smart Lipo capsules, a dietary supplement promoted for weight loss, due to the presence of undeclared ingredients.

Cholesterol Combo Drug Discontinued

Merck has reported to the Food and Drug Administration (FDA) that all Liptruzet (ezetimibe/atorvastatin) tablets have been discontinued.