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American Regent initiates voluntary nationwide recall of Dexamethasone

Many OPOs utilize Dexamethasone Sodium Phosphate as an additive for organ preservation solutions. UNOS would like to call your attention to a voluntary recall, initiated on March 16, 2011, for ALL unexpired lots of 3 different sizes of Dexamethasone Sodium Phosphate Injection, USP.

This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. 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 due to accumulation of inflammatory cells), and granuloma formation.

Read Appendix for Lot #s, Expiration Dates and Dates of First Distribution.

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