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Haloperidol Decanoate Injection

[13 October 2014]

Products Affected - Description

Haloperidol decanoate injection, Fresenius Kabi (formerly APP)
50 mg/mL, 5 mL vial (NDC 63323-0469-05)
100 mg/mL, 1 mL vial (NDC 63323-0471-01)
100 mg/mL, 5 mL vial (NDC 63323-0471-05)
 
Haloperidol decanoate injection, Teva
50 mg/mL, 1 mL vial (NDC 00703-7011-03)
50 mg/mL, 5 mL vial (NDC 00703-7013-01)
100 mg/mL, 1 mL vial (NDC 00703-7021-03)
100 mg/mL, 5 mL vial (NDC 00703-7023-01)

Reason for the Shortage

  • Teva products are on shortage due to manufacturing delays.
  • Fresenius Kabi could not provide a reason for the shortage.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired haloperidol decanoate injection from Bedford in July 2014. West-Ward is not actively marketing haloperidol decanoate injection at this time.

Available Products

Haloperidol decanoate injection, Fresenius Kabi (formerly APP)
50 mg/mL, 1 mL vial (NDC 63323-0469-01)

Haldol decanoate injection, JOM
50 mg/mL, 1 mL ampule (NDC 50458-0253-03)
100 mg/mL, 1 mL ampule (NDC 50458-0254-14)
 
Haloperidol decanoate injection, Patriot Pharmaceuticals
50 mg/mL, 1 mL ampule (NDC 10147-0921-03)
100 mg/mL, 1 mL ampule (NDC 10147-0922-05)

Estimated Resupply Dates

  • Fresenius Kabi has haloperidol decanoate 50 mg/mL 5 mL vials available with expiration dating of December 2014 and March 2015. Haloperidol decanoate 100 mg/mL 1 mL vials are on back order with an estimated release date of October 2014. The 100 mg/mL 5 mL vials are also on back order with an estimated release date of early-November 2014.
  • Teva has all haloperidol decanoate presentations on long-term back order and the company estimates a release date in 3rd quarter 2015.

Related Shortages

Updated

October 13, 2014; September 24, 2014; September 3, 2014; August 7, 2014; July 17, 2014; June 30, 2014; April 24, 2014; February 24, 2014; December 11, 2013; September 30, 2013; August 5, 2013; June 3, 2013; March 22, 2013; February 28, 2013; December 12, 2012; October 10, 2012; June 1, 2012; April 6, 2012; March 19, 2012; March 9, 2012; January 27, 2012; December 21, 2011; October 4, 2011; August 4, 2011; June 23, 2011; May 27, 2011; April 13, 2011; March 22, 2011; March 9, 2011; February 28, 2011; February 2, 2011; January 25, 2011; January 6, 2011; December 15, 2010; November 15, 2010; October 14, 2010; October 1, 2010; August 30, 2010; July 20, 2010; July 9, 2010; July 7, 2010; June 25, 2010; June 17, 2010; May 21, 2010; April 30, 2010; March 18, 2010; February 17, 2010; January 11, 2010; May 12, 2009; April 1, 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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