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Labetalol Injection

[28 August 2014]

Products Affected - Description

Labetalol injection 5 mg/mL, West-Ward (formerly Bedford product)
20 mL vials (NDC 55390-0130-20)
40 mL vials (NDC 55390-0130-40)
 
Labetalol injection 5 mg/mL, Sagent
20 mL vials (NDC 25021-0300-20) - suspended manufacturing
40 mL vials (NDC 25021-0300-40) - suspended manufacturing

Reason for the Shortage

  • Hospira had labetalol on shortage due to manufacturing delays and increased demand.
  • Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The company could not provide a reason for the discontinuation.
  • Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013.
  • Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013 and 40 mL vials in February 2014.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including labetalol injection. West-Ward is not actively marketing labetalol injection.

Available Products

Labetalol injection, 5 mg/mL, Akorn
20 mL vial (NDC 17478-0420-20)
40 mL vials (NDC 17478-0420-40)    
 
Labetalol injection 5 mg/mL, Hospira
4 mL Carpuject syringe (NDC 00409-2339-34)
20 mL vial (NDC 00409-2267-20)
40 mL vial (NDC 00409-2267-54)
 

Estimated Resupply Dates

  • Sagent suspended manufacture of labetalol 5 mg/mL 20 mL and 40 mL vials and the company has no estimated release date for further production.
  • West-Ward is not actively marketing labetalol injection.

Related Shortages

Updated

August 28, 2014; June 24, 2014; June 6, 2014; May 22, 2014; May 1, 2014; March 31, 2014; February 27, 2014; February 10, 2014; February 7, 2014; December 27, 2013; September 13, 2013; August 30, 2013; July 16, 2013; June 13, 2013; May 7, 2013; April 17, 2013; March 27, 2013; January 29, 2013; December 20, 2012; November 30, 2012; October 31, 2012; September 17, 2012; July 26, 2012; June 21, 2012; May 2, 2012; April 26, 2012; April 13, 2012; April 4, 2012; February 3, 2012; January 27, 2012; December 20, 2011; November 23, 2011; November 3, 2011; October 26, 2011; October 6, 2011; September 14, 2011; August 26, 2011; August 25, 2011; June 30, 2011; May 23, 2011; May 12, 2011; April 22, 2011; March 30, 2011; March 14, 2011; March 1, 2011; February 2, 2011; January 21, 2011, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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