Pharmacy Services
Hydralazine HCl 20mg/mL Injection - Recall
August 18, 2006
The FDA and Luitpold Pharmaceuticals have issued a voluntary recall of several lots of hydralazine 20 mg/mL injection in 1 mL single-dose vials. The affected product may contain particulates. The following lots are affected by this recall:
- Novaplus label:
- Lot #5411NO, exp 9/06
- Lot #5457NO, exp 11/06
- Lot #5561NO, exp 12/06
- Lot #5669NO, exp 1/07
- Lot #5710NO, exp 2/07
- Lot #5784NO, exp 6/07
- Lot #5797NO, exp 6/07
- Lot #6411NO, exp 12/07
- American Regent label:
- Lot #5411, exp 9/06
- Lot #5457, exp 11/06
- Lot #5552, exp 12/06
- Lot #5647, exp 1/07
- Lot #5669, exp 1/07
- Lot #5753, exp 3/07
- Lot #6411, exp 12/07
The company has requested that healthcare providers immediately quarantine any product from these lots and return it to the distributor, American Regent. Contact American Regent’s Director of Customer Service at (631) 924-4000, ext. 142 to arrange product returns. The company will pay shipping costs and issue credit for returned recalled products.
Additional information and return instructions are available online at the following links:
- MedWatch Alert:,br> http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150605.htm
- Updated Recall Letter and Return Instructions from American Regent, 8/11/06:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM153263.pdf - Recall Letter and Return Instructions from American Regent, 7/24/06:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM153265.pdf
Updated
August 18, 2006; August 11, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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