[13 May 2013]
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, Teva
10 mL vial (NDC 00703-7045-01)
Reason for the Shortage
- Bedford has haloperidol lactate on shortage due to manufacturing delays.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.
- Teva has haloperidol lactate on shortage due to manufacturing delays.
Available Products
Haloperidol lactate 5 mg/mL injection, APP
1 mL vial (NDC 63323-0474-01)
10 mL vial (NDC 63323-0474-10)
Haldol lactate 5 mg/mL injection, Ortho-McNeil
1 mL ampules (NDC 50458-0255-01)
Haloperidol lactate 5 mg/mL injection, Patriot Pharmaceuticals
1 mL ampules (NDC 10147-0911-01)
Haloperidol lactate 5 mg/mL injection, Pfizer
1 mL vial (NDC 00069-0113-02)
Haloperidol lactate 5 mg/mL injection, Sagent
1 mL vial (NDC 25021-0806-01)
10 mL vial (NDC 25021-0823-10)
Estimated Resupply Dates
- Bedford has all haloperidol lactate presentations on back order and the company cannot estimate a release date. Haloperidol 5 mg/mL 10 mL vials are on a long-term back order and will not be manufactured until capacity permits.
- Teva has haloperidol lactate 5 mg/mL 10 mL vials on long term back order and the company cannot estimate a release date.
Related Shortages
Updated
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; May 7, 2012; April 11, 2012; March 19, 2012; March 9, 2012; February 9, 2012; February 8, 2012; January 27, 2012; December 21, 2011; December 2, 2011; November 14, 2011; November 2, 2011; October 13, 2011; October 5, 2011; September 22, 2011; August 24, 2011; August 11, 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; October 14, 2010; October 1, 2010; September 16, 2010; September 9, 2010; August 30, 2010; August 18, 2010; July 7, 2010; December 18, 2009; December 4, 2009; October 29, 2009; October 8, 2009; September 21, 2009; August 26, 2009; August 6, 2009; June 30, 2009; University of Utah, Drug Information Service. Copyright 2013, University of Utah, Drug Information Service.
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