Safety Alerts and Recalls

Safety Alerts & Recalls

Withdrawn, Unapproved Drugs Detected in Weight Loss Pills

The Food and Drug Administration (FDA) is warning consumers not to buy or use ZeroXtreme Capsules and Akttive Capsules, supplements marketed for weight loss, due to the presence of undeclared ingredients.

Diazepam Sold Online May Actually Be Antipsychotic, FDA Warns

The Food and Drug Administration (FDA) issued a warning about the potential risk of purchasing counterfeit diazepam online.

Recall: Antipsychotic Found in Bottle Labeled for GERD Medication

AstraZeneca announced a voluntary recall of 34,524 bottles of Nexium (esomeprazole magnesium) delayed-release capsules following the discovery of a bottle containing Seroquel XR (quetiapine fumarate) extended-release tablets instead.

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.