American Regent has expanded its voluntary nationwide recall of ketorolac tromethamine injection to include all lots of ketorolac tromethamine injection 15mg/mL, 1mL single-dose vial; NDC# 0517-0601-25. This recall is in addition to the one initiated on October 16, 2009 when American Regent voluntarily recalled all unexpired lots of ketorolac tromethamine injection 30mg/mL due to the presence of particulate matter in conjunction with crystallization. Healthcare facilities should immediately quarantine any of the recalled ketorolac tromethamine injection 15mg/mL and 30mg/mL products for return.

Ketorolac tromethamine for IV or IM injection is a nonsteroidal antiinflammatory drug (NSAID) indicated for the management of moderately severe, acute pain requiring opioid-level analgesia.

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