Voluntary recall because the manufacturer cannot assure the sterility of affected lots of vaccine.

Changes made to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of prescribing information regarding postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade.

Dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502.

FDA's follow-up communication regarding its review of safety data that raised concerns about a potential increased risk of heart problems for patients treated with these drugs.

Use of drug during pregnancy associated with increased risks of pregnancy loss and congenital malformations.

Product recalled because it contains potentially harmful, undeclared ingredients.

Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Encore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Encore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED).

Product recall expanded to include Energy Max, Energy Supplement Men's Formula with the expiration date up to and including December 2010.

Information for Healthcare Professionals Sheet highlights a new BOXED WARNINGS and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of prescribing information about the potential increased risk of myocardial ischemia.

American True Man Health Incorporated announced that it is expanding it's voluntary recall of the Company's dietary supplement product sold under the name and identified as True Man's Sexual Energy Nutriment Men's Formula with the expiration date up to and including December 2010 to also include the dietary supplement product sold under the name and identified as Energy Max, Energy Supplement Men's Formula (the products) with the expiration date up to and including December 2010. Finished products from several lots of these products were tested and were found to contain an analog of an ingredient in an FDA-approved drug. The analog resembles the active pharmaceutical ingredients in Tadalafil, Vardenafil, and Sildenefil, FDA-approved drugs used to treat erectile dysfunction (ED). Consequently, the products may possess a similar pharmacological and adverse event profile, posing a threat to consumers because of interaction with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Early communication about the ongoing review of new safety data to evaluate the risk of death in patients treated with cefepime.