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Phentolamine Mesylate for Injection

Last Updated: December 2, 2015
Status: Resolved

Products Affected - Description

Phentolamine Mesylate injection, West-Ward
5 mg, vial (NDC 55390-0113-01) - discontinued

Reason for the Shortage

  • West-Ward received FDA approval for phentolamine injection in Fall 2015.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired phentolamine injection from Bedford in July 2014. West-Ward discontinued the Bedford phentolamine product in early-January 2015.
  • Novartis discontinued marketing the brand name product Regitine in the US in 2000.
  • Sandoz Canada temporarily provided phentolamine mesylate to the US market (NDC 00781-3028-95) from May 2012 to early 2013.

Available Products

Phentolamine Mesylate injection, West-Ward
5 mg, vial (NDC 00143-9564-10)

Estimated Resupply Dates

West-Ward launched phentolamine injection in early-November 2015 and product is available.

Related Shortages


December 2, November 4, October 8, January 22 and 21, 2015; November 26, October 28, 23 and 2, 2014, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.