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Article: AMERICAN REGENT EXPANDS VOLUNTARY RECALL TO INCLUDE ALL LOTS OF KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML; 1ML SINGLE DOSE VIALS
- Article from:
- US Fed News Service, Including US State News
- Article date:
- November 4, 2009
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SHIRLEY, N.Y., Nov. 3 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following recall notice:
American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:
NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial
PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.
This voluntary recall is due to the potential that particulates from crystallization may be present in ...