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Haloperidol Lactate Injection

[14 July 2014]

Products Affected - Description

Haloperidol lactate 5 mg/mL injection, Bedford
1 mL vial (NDC 55390-0147-10)
10 mL vial (NDC 55390-0147-01)     
 
Haloperidol lactate 5 mg/mL injection, Fresenius Kabi (formerly APP)
10 mL vial (NDC 63323-0474-10)
 
Haloperidol lactate 5 mg/mL injection, Mylan Institutional (formerly a Pfizer product)
1 mL vial (NDC 67457-0426-12)
 
Haloperidol lactate 5 mg/mL injection, Patriot Pharmaceuticals
1 mL ampules (NDC 10147-0911-01)
 
Haloperidol lactate 5 mg/mL injection, Sagent
1 mL vial (NDC 25021-0806-01) 
10 mL vial (NDC 25021-0823-10)
 
Haloperidol lactate 5 mg/mL injection, Teva
10 mL vial (NDC 00703-7045-01)

Reason for the Shortage

  • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.
  • Mylan Institutional could not provide a reason for the shortage.
  • Sagent has haloperidol lactate on shortage due to manufacturing delays.
  • Teva has haloperidol lactate on shortage due to manufacturing delays.
  • Mylan Institutional acquired haloperidol lactate injection from Pfizer on December 6, 2013.
  • Patriot Pharmaceuticals states the reason for the shortage is increased demand.

Available Products

Haloperidol lactate 5 mg/mL injection, Fresenius Kabi (formerly APP)
1 mL vial (NDC 63323-0474-01)
 
Haldol lactate 5 mg/mL injection, Janssen (formerly Ortho-McNeil)
1 mL ampules (NDC 50458-0255-01)

Estimated Resupply Dates

  • Bedford has all haloperidol lactate presentations on long-term back order and the company cannot estimate a release date. Ben Venue manufactured haloperidol lactate injection for Bedford.
  • Fresenius Kabi has haloperidol lactate 5 mg/mL 10 mL vials on back order and the company estimates a release date of late-July 2014. Short-dated product is available.
  • Mylan Institutional has temporarily discontinued haloperidol lactate 5 mg/mL 1 mL vials and the company cannot estimate when product will return.
  • Patriot has haloperidol lactate 5 mg/mL 1 mL ampules on allocation.
  • Sagent has haloperidol lactate 5 mg/mL 1 mL and 10 mL vials on back order and the company estimates a release date in late-August 2014.
  • Teva has haloperidol lactate 5 mg/mL 10 mL vials on long term back order and the company estimates a release date in 2nd quarter of 2015.

Related Shortages

Updated

July 14, 2014; June 12, 2014; June 3, 2014; May 29, 2014; May 28, 2014; May 21, 2014; May 8, 2014; April 10, 2014; March 3, 2014; February 21, 2014; December 11, 2013; November 6, 2013; September 13, 2013; August 29, 2013; May 13, 2013; April 12, 2013; March 29, 2013; February 14, 2013; December 5, 2012; November 16, 2012; October 16, 2012; September 5, 2012; June 27, 2012; May 9, 2012; April 11, 2012; March 9, 2012; February 9, 2012; January 27, 2012; December 21, 2011; November 14, 2011; October 13, 2011; September 22, 2011; August 24, 2011; June 17, 2011; June 2, 2011; April 13, 2011; March 3, 2011; January 25, 2011; January 6, 2011; December 15, 2010; November 15, 2010; October 29, 2010; September 16, 2010; September 9, 2010; August 30, 2010; August 18, 2010; July 7, 2010; June 30, 2009;  University of Utah, Drug Information Service. Copyright 2014, University of Utah, Drug Information Service.

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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