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Ondansetron Injection

[07 July 2014]

Products Affected - Description

Ondansetron 2 mg/mL vials
Ondansetron injection, 2 mg/mL, Bedford
20 mL vial (NDC 55390-0121-01)
 
Ondansetron injection, 2 mg/mL, Hospira
2 mL vials, packages of 25 (NDC 00409-4755-03)
20 mL vials (NDC 00409-4759-01)

Ondansetron injection, 2 mg/mL, Mylan Institutional
2 mL vials, package of 25 (NDC 00069-1340-16)
20 mL vials (NDC 00069-1340-02)
 
Ondansetron injection, 2 mg/mL, Teva
20 mL vials (NDC 00703-7226-01)
20 mL vials, packages of 10 (NDC 00703-7226-03)
 
Ondansetron injection, 2 mg\mL, Wockhardt
2 mL vials, packages of 5 (NDC 64679-0726-01)
20 mL vials (NDC 64679-0727-01)
 
Ondansetron injection, 2 mg/mL, West-Ward
2 mL vials, packages of 25 (NDC 00143-9891-25) - discontinued

Ondansetron 32 mg/50 mL premixed bags
Ondansetron injection, premixed bags, Baxter
32 mg/50 mL (NDC 00338-1762-41) - discontinued

Ondansetron injection, premixed bags, Bedford
32 mg/50 mL (NDC 55390-0234-01) - discontinued

Ondansetron injection, premixed bags, Claris
32 mg/50 mL (NDC 36000-0014-06)- discontinued

Ondansetron injection, premixed bags, Teva
32 mg/50 mL (NDC 00703-7239-39) - discontinued

Ondansetron injection, premixed bags, Hospira
32 mg/50 mL (NDC 00409-4760-24) - discontinued

Reason for the Shortage

Ondansetron 2 mg/mL vials

  • Caraco temporarily discontinued ondansetron injection.
  • West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward discontinued ondansetron 2 mg/mL vials in packages of 5 in Spring, 2012.
  • BD launched ondansetron 2 mg/mL prefilled syringes in September 2013. 
  • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. 
  • Hospira has ondansetron on shortage due to manufacturing delays.
  • Mylan Institutional acquired ondansetron injection from Pfizer on December 7, 2013. Mylan Institutional temporarily discontinued ondansetron 2 mg/mL injectable products in February 2014.
  • Teva is temporarily discontinuing ondansetron 20 mL injection. The company does not have plans to manufacture additional product after the short-dated product is depleted.  
  • West-Ward had ondansetron on back order due to increased demand.
  • Wockhardt has ondansetron injection on shortage due to an FDA import alert.

Ondansetron 32 mg/50 mL premixed bags

  • All presentations of ondansetron 32 mg/50 mL premixed bags have been discontinued.
  • Single-dose IV ondansetron 32 mg is no longer recommended due to an increased potential for QT prolongation and has been removed from the Zofran product labeling. The maximum dose for chemotherapy-induced nausea should not exceed 16 mg. FDA is working with manufacturers to voluntarily recall all ondansetron 32 mg premixed bags from the market by early 2013. Oral ondansetron dosing is not affected by the new recommendations, including the 24 mg oral dose for chemotherapy-induced nausea and vomiting.
  • Baxter has discontinued and recalled their ondansetron premixed bags.
  • Bedford discontinued their ondansetron premixed bags in December, 2012.
  • Hospira discontinued their ondansetron premixed bags in December, 2012. Product has not been available on the market for several years.
  • Claris recalled all lots of their ondansetron premixed bags in mid-2010.
  • Claris discontinued their ondansetron premixed bags in June 2013.    
  • Pfizer discontinued their ondansetron premixed bags in January, 2012.
  • Teva discontinued their ondansetron premixed bags in late-November, 2012. Product has not shipped since early 2010.
  • West-Ward has discontinued their ondansetron premixed bags.

Available Products

Ondansetron 2 mg/mL vials
Ondansetron injection, 2 mg/mL, Fresenius Kabi
2 mL vials, package of 25 (NDC 63323-0373-02)
20 mL multiple dose vials (NDC 63323-0374-20)
 
Ondansetron injection, 2mg/mL, AuroMedics
2 mL vials, package of 25 (NDC 55150-0125-02)
20 mL vials (NDC 55150-0126-20)

Ondansetron injection, 2 mg/mL, BD
2 mL prefilled syringe, package of 24 (NDC 76045-0103-20)
 
Zofran injection, 2 mg/mL, GlaxoSmithKline
20 mL vial (NDC 00173-0442-00)
 
Ondansetron injection, 2 mg/mL, Heritage
2 mL vials, package of 10 (NDC 23155-0196-42)
20 mL vials (NDC 23155-0168-31)

Ondansetron injection, 2 mg/mL, Hospira
2 mL iSecure syringe (NDC 00406-1120-12)

Ondansetron injection, 2 mg/mL, Sagent
2 mL vials, package of 25 (NDC 25021-0777-02)
20 mL vials (NDC 25021-0782-20)

Ondansetron injection, 2 mg/mL, Teva
2 mL vials, packages of 25 (NDC 00703-7221-04)
 
Ondansetron injection, 2 mg/mL, The Medicines Company
2 mL vials (NDC 65293-0373-25)
20 mL vial (NDC 65293-0374-01)

Ondansetron injection, 2 mg/mL, West-Ward
2 mL vials, packages of 25 (NDC 00641-6078-25)
20 mL vials (NDC 00143-9890-01)
20 mL vials (NDC 00641-6079-01)

Estimated Resupply Dates

Ondansetron 2 mg/mL vials
  • Bedford has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate a release date. Ben Venue manufactured ondansetron injection for Bedford.
  • Hospira has ondansetron 2 mg/mL 2 mL vials on back order with an estimated release date of July 2014. Hospira has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date in 4th quarter 2014.
  • Mylan Institutional has ondansetron 2 mg/mL 2 mL and 20 mL vials on back order and the company cannot estimate a release date.
  • Teva has ondansetron 2 mg/mL 20 mL presentations on back order and the company cannot estimate a release date.
  • Wockhardt has ondansetron 2 mL and 20 mL vials on back order and the company cannot estimate a release date.

Related Shortages

Updated

July 7, 2014; June 13, 2014; April 28, 2014; March 31, 2014; March 3, 2014; February 5, 2014; January 24, 2014; December 12, 2013; December 6, 2013; November 20, 2013; November 4, 2013; October 23, 2013; September 23, 2013; August 14, 2013; July 2, 2013; June 19, 2013; May 30, 2013; May 24, 2013; April 5, 2013; March 8, 2013; February 6, 2013; January 11, 2013; December 13, 2012; December 5, 2012; November 28, 2012; November 7, 2012; October 26, 2012; October 10, 2012; September 19, 2012; September 12, 2012; August 3, 2012; July 25, 2012; July 5, 2012; June 28, 2012; June 15, 2012; May 25, 2012; May 11, 2012; May 8, 2012; April 24, 2012; March 28, 2012; March 27, 2012; February 29, 2012; February 3, 2012; January 20, 2012; December 16, 2011; December 1, 2011; November 23, 2011; October 27, 2011; September 30, 2011; September 19, 2011; January 21, 2011; 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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