Exjade receives black b...

Novartis Oncology and FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the...

Baxter HomeChoice Dialy...

Company, Product(s): Baxter Healthcare Corporation HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems Recall Class: Class I Date Recall Initiated: January 8, 2010 Product Names: Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis...

Cough and cold products...

FOR IMMEDIATE RELEASE — Clearwater, Fl. – April 13, 2009 — ION Labs Inc. of Clearwater, FL. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products due to the products not tested in...

FDA Scientists blast Ag...

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 April 2, 2009 The Honorable Barack H. Obama President of the United States 1600 Pennsylvania Avenue NW Washington, DC 20500 Dear Mr....

More Digoxin tablets re...

Poor Quality Control Leads to Varying Amount of Active Ingredient Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not...

Children’s Bath P...

WASHINGTON, DC (March 12, 2009) — Despite marketing claims like “gentle” and “pure,” dozens of top-selling children’s bath products are contaminated with the cancer-causing chemicals formaldehyde and 1,4-dioxane, according to product test results...

Transdermal drug patche...

FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is...

Fraud during clinical t...

Colorado Springs, CO (March 11, 2009) – On Friday, March 6, 2009, Coast IRB notified Criminal Fraud unit of the U.S. Department of Justice, the FBI, the FDA, and the Commonwealth of Virginia Department of Health Professions of a fraudulent clinical test. Coast Independent Review...

GSK accused of conducti...

The watchdog agency, Wemos International, which works to protect human subjects in clinical trials, today accused GlaxoSmithKline (GSK) and AstraZeneca of running unethical clinical trials in India. GSK GSK tested the breast cancer drug lapatinib in India.  The drug, lapatinib, has been...

Generic drug manufactur...

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa; KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now...