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U.S. Department of Health and Human Services

Safety

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Hydralazine HCl Injection, USP, 20 mg/mL

Audience: Cardiologists, pharmacists and other healthcare professionals
[Updated 8/25/2006] Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall of additional lots of Hydralazine HCl Injection (20 mg/mL, 1 mL single dose vials) because the products may contain particulates.

[Posted 08/03/2006] 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.

[August 11, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]
[July 24, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]