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Granisetron Hydrochloride Injection

Last Updated: July 15, 2014
Status: Resolved

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.

Related Shortages

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.

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