[24 April 2013]
Products Affected - Description
Valproate injection, Bedford
100 mg/mL, 5 mL vials (NDC 55390-0007-10)
Reason for the Shortage
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.
Available Products
Valproate injection, APP
100 mg/mL, 5 mL vials (NDC 63323-0494-05)
Valproate injection, West-Ward
100 mg/mL, 5 mL vials (NDC 00143-9785-10)
Depacon injection, Abbvie
100 mg/mL, 5 mL vials (NDC 00074-1564-10)
Estimated Resupply Dates
Bedford has valproate 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.
Related Shortages
Updated
April 24, 2013; March 20, 2013; January 24, 2013; November 20, 2012; November 14, 2012; September 19, 2012; July 18, 2012; May 22, 2012; March 9, 2012; February 8, 2012; January 4, 2012; November 23, 2011; November 21, 2011; November 15, 2011; November 8, 2011; November 1, 2011; October 4, 2011; August 17, 2011; July 20, 2011; July 1, 2011; June 29, 2011; June 23, 2011; June 7, 2011; April 14, 2011, University of Utah, Drug Information Service. Copyright 2013, 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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