August 4, 2006

FDA ALERT

FDA MedWatch - Hydralazine HCl Injection, USP 20 mg/mL ( Luitpold Pharmaceuticals, Inc.): Single lot recalled due to the potential that some vials may contain particulates

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall because some vials of Hydralazine HCl Injection from lot number 5561 NO with an expiration date of December, 2006 (20 mg/mL, 1 mL single dose vials) may contain particulates. The lot is labeled with a NOVAPLUS label. Further use or distribution of this lot of product should cease.

Read the complete MedWatch 2006 Safety Summary, including a link to the Luitpold Pharmaceuticals, Inc., Recall Letter, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Hydralazine

Hydralazine (Systemic)

Hydralazine (hye-DRAL-a-zeen) belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in the mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.