FDA NEWS

Mommy's Bliss Nipple Cream
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

FDA Safety Update: Asthma Medications
May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications.

Cardinal Alcohol-Free Mouthwash
Product recalled because of the presence of Burkholderia cepacia.

Sentinel System to Monitor Medical Product Safety
FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance.

FDA Takes Action Against Scientific Laboratories Inc.
A permanent injunction bars Scientific Laboratories from making and distributing drug products until its manufacturing operations comply with law and its products are approved.

Xiadafil VIP Tablets
Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.

Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.

Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death.