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Granisetron Hydrochloride Injection

[15 July 2014]

Products Affected - Description

Granisetron Hydrochloride Injection, Teva
0.1 mg/mL, 1 mL vial (NDC 00703-7891-01)
1 mg/mL, 1 mL vial (NDC 00703-7971-03)
1 mg/mL, 4 mL vial (NDC 00703-7973-01)
 
Granisetron Hydrochloride Injection, Wockhardt
1 mg/mL, 1 mL vial (NDC 64679-0661-03)
1 mg/mL, 4 mL vial (NDC 64679-0661-02)

Reason for the Shortage

  • Akorn discontinued granisetron 0.1 mg/mL 1 mL vials in August, 2011.
  • Apotex and Baxter discontinued their granisetron hydrochloride presentations.
  • Fresenius Kabi states the shortage was due to manufacturing delays.
  • Bedford discontinued granisetron in May, 2011 to concentrate on the manufacturing of other products.
  • Roche discontinued Kytril 0.1 mg/mL and 1 mg/mL 1 mL vials in October, 2009. They discontinued the 1 mg/mL 4 mL vials in July 2010.
  • Teva states the shortage is due to manufacturing delays and product is not expected until at least 2016.
  • Wockhardt discontinued granisetron hydrochloride injection 0.1 mg/mL 1 mL vials in early, 2010.
  • FDA imposed an import ban in mid-2013 on several Wockhardt products including granisetron 1 mg/mL 1 mL and 4 mL vials. There is no estimated date on when this ban may be lifted.
  • Sagent had granisetron on shortage due to increased demand.   
  • Sandoz had granisetron on shortage due to increased demand.

Available Products

Granisetron Hydrochloride Injection, Akorn
1 mg/mL, 1 mL vial (NDC 17478-0546-02)
1 mg/mL, 4 mL vial (NDC 17478-0546-05)
 
Granisetron Hydrochloride Injection, Fresenius Kabi
0.1 mg/mL, 1 mL vial (NDC 63323-0317-01)
1 mg/mL, 1 mL vial (NDC 63323-0318-01)
1 mg/mL, 4 mL vial (NDC 63323-0319-04)
 
Granisetron Hydrochloride Injection, Sagent
0.1 mg/mL, 1 mL vial (NDC 25021-0778-01)
0.1 mg/mL, 1 mL Novaplus vial (NDC 25021-0778-66)
1 mg/mL, 1 mL vial (NDC 25021-0779-01)
1 mg/mL, 4 mL vial (NDC 25021-0781-04)
 
Granisetron Hydrochloride Injection, Sandoz
1 mg/mL, 1 mL vial (NDC 66758-0035-01)
1 mg/mL, 4 mL vial (NDC 66758-0036-01)
 
Granisetron Hydrochloride Injection, West-Ward
1 mg/mL, 1 mL vial (NDC 00143-9744-10)
1 mg/mL, 4 mL vial (NDC 00143-9745-05)

Estimated Resupply Dates

Manufacturers with available products are able to fully supply the market.

Updated

July 15, 2014; June 16, 2014; May 21, 2014; May 1, 2014; March 25, 2014; March 5, 2014; January 24, 2014; November 11, 2013; October 16, 2013; October 11, 2013; July 29, 2013; June 4, 2013; May 9, 2013; April 5, 2013; March 5, 2013; January 14, 2013; December 12, 2012; November 2, 2012; October 5, 2012; August 17, 2012; July 26, 2012; May 29, 2012; May 2, 2012; April 26, 2012; April 4, 2012; March 29, 2012; March 2, 2012; February 3, 2012; January 27, 2012; December 16, 2011; November 16, 2011; October 4, 2011; August 17, 2011; July 29, 2011; June 9, 2011; May 4, 2011; April 27, 2011; April 14, 2011; March 25, 2011; February 28, 2011; January 20, 2011; December 8, 2010; October 22, 2010; October 15, 2010; September 29, 2010; August 17, 2010; July 1, 2010; June 28, 2010; May 14, 2010, 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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