February 24, 2012
American Regent voluntarily recalled one lot of phenylephrine injection (Lot #0693) because visible glass particles were present in some vials. Serious adverse events or death are possible if particulate matter is injected intravenously, intrathecally, or subconjunctivally. No adverse events have been reported to date due to this recall.
American Regent advises healthcare facilities and providers to not use these products. Quarantine and return all affected products. Contact American Regent Customer Service (1-800-645-1706) to help facilitate returns or for other questions regarding the recall. Contact American Regent Professional Services Department (1-877-788-3232) to report adverse events or with medical questions associated with the use of affected product. Adverse events may also be reported to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm).
Additional information is available at the following links:
- FDA MedWatch Alert (includes previous products recalled by American Regent):
- American Regent Press Release:
February 24, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.