Safety Alerts and Recalls

Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease or systemic lupus erythematosus.

Sapropterin Dihydrochloride Powder for Oral Solution is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.

Unpacking and figuring out how to use an anti-choking device can waste valuable time, the agency said

The Company is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life.

At this time, there have been no reports of adverse events associated with this recall.

The updates were prompted by findings from an investigation of reports describing mature T-cell malignancies among patients treated with these therapies.

Hundreds of injuries and 14 deaths have been linked to the devices

The Agency is cracking down on the sale of this type of tobacco product in which nicotine is absorbed from a small pouch that is held between the user’s lip and gum.

All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.

Atovaquone Oral Suspension is a quinone antimicrobial drug indicated for prevention and treatment of Pneumocystis jiroveci pneumonia.