American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates
MedSun: Newsletter #62, July 2011

American Regent Press Release

This recall, initiated on June 6, 2011 to the User or Consumer Level, is for Lot # 0152 only. No other lots of Methyldopate HCL Injection, USP are subject to this voluntary recall. This voluntary recall was initiated because some of the vials of this lot contained translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of Methyldopate HCL Injection, USP is administered to patients. American Regent has not received any reports of adverse events related to this recall.

Additional Information:

American Regent Press Release. American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates. June 6, 2011.
http://www.fda.gov/Safety/Recalls/ucm258064.htm


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