American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter

American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter
Tue, 26 Apr 2011 17:14:00 -0500

This voluntary recall was initiated because some vials of this lot were observed to contain particulates. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lungs, localized inflammation (swelling and accumulation of inflammatory cells), and granuloma formation.

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