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Ondansetron Injection

[17 April 2015]

Products Affected - Description

Ondansetron injection, AuroMedics
2mg/mL, 2 mL vials, 25 count (NDC 55150-0125-02)

Zofran injection, GlaxoSmithKline
2 mg/mL, 20 mL vial, single-count (NDC 00173-0442-00)

Ondansetron injection, Heritage
2 mg/mL, 2 mL vials, 10 count (NDC 23155-0196-42)
2 mg/mL, 20 mL vials, single-count (NDC 23155-0168-31)

Ondansetron injection, The Medicines Company
2 mg/mL, 2 mL vials, 25 count (NDC 65293-0373-25)
2 mg/mL, 20 mL vial, single-count (NDC 65293-0374-01)

Ondansetron injection, Mylan Institutional
2 mg/mL, 2 mL vials, 25 count (NDC 00069-1340-16) - NDC discontinued
2 mg/mL, 20 mL vials, single-count (NDC 00069-1340-02) - NDC discontinued

Ondansetron injection, Sagent
2 mg/mL, 2 mL vials, 25 count (NDC 25021-0777-02)
 
Ondansetron injection, Teva
2 mg/mL, 20 mL vials, single-count (NDC 00703-7226-01)
2 mg/mL, 20 mL vials, 10 count (NDC 00703-7226-03) 

Reason for the Shortage

  • AuroMedics did not provide a reason for the shortage.
  • Caraco temporarily discontinued ondansetron injection.
  • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July, 2014.
  • Heritage cannot provide a reason for the shortage.
  • Mylan Institutional has new NDC numbers for ondansetron 2 mg/mL injectable products.
  • Sagent has ondansetron on back order due to increased demand.
  • Teva re-launched ondansetron 20 mL injection in 2015.
  • West-Ward had ondansetron on back order due to increased demand.
  • Wockhardt has ondansetron injection on an FDA import alert.
  • All presentations of ondansetron 32 mg/50 mL premixed bags have been discontinued.

Available Products

Ondansetron injection, AuroMedics
2mg/mL, 20 mL vials, single-count (NDC 55150-0126-20)

Ondansetron injection, BD
2 mg/mL, 2 mL prefilled syringe, 24 count (NDC 76045-0103-20)

Ondansetron injection, Fresenius Kabi
2 mg/mL, 2 mL vials, 25 count (NDC 63323-0373-02)
2 mg/mL, 20 mL vials, single-count (NDC 63323-0374-20)

Ondansetron injection, Hospira
2 mg/mL, 2 mL vials, 25 count (NDC 00409-4755-03)
2 mg/mL, 20 mL vials, single-count (NDC 00409-4759-01)
2 mg/mL, 2 mL iSecure syringe, 10 count (NDC 00409-1120-12)

Ondansetron injection, Mylan Institutional
2 mg/mL, 2 mL vials, 25 count (NDC 67457-0441-20)
2 mg/mL, 20 mL vials, single-count (NDC 67457-0440-20)

Ondansetron injection, Sagent
2 mg/mL, 20 mL vials, single-count (NDC 25021-0782-20)

Ondansetron injection, Teva
2 mg/mL, 2 mL vials, 25 count (NDC 00703-7221-04)
2 mg/mL, 20 mL vials, single count (NDC 00703-7226-01)
2 mg/mL, 20 mL vials, 25 count (NDC 00703-7226-03)

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

Estimated Resupply Dates

  • AuroMedics has ondansetron 2 mg/mL 2 mL vials on intermittent back order with regular releases.
  • GlaxoSmithKline has Zofran 2 mg/mL 20 mL vials on back order and the company estimates a release date in early-May 2015.
  • Heritage has ondansetron 2 mL and 4 mL vials temporarily unavailable and the company cannot estimate a release date.
  • The Medicines Company has ondansetron 2 mg/mL 2 mL and 20 mL presentations on back order and the company cannot estimate a release date.
  • Sagent has ondansetron 2 mL vials on back order and the company cannot estimate a release date.
  • West-Ward has ondansetron 20 mL vials (NDC 00143-9890-01) available with both regular and short expiration dating (October, November, or December 2015). The 20 mL vials (NDC 00641-6079-01) are also available with both regular and short expiration dating (February 2016).

Related Shortages

Updated

April 8 and 17, March 11, February 19, January 23, 2015; December 18 and 22, November 17, October 29, September 24, August 21, July 7, June 13, April 28, March 31, February 5, January 24, 2014; December 12, November 20, October 23, September 23, August 14, July 2, June 19, May 30, April 5, March 8, February 6, January 11, 2013; December 5 and 13, November 7 and 28, October 5, 10, and 26, September 19, August 3, July 25, June 28, May 25, April 24, March 28, February 29, January 20, 2012; December 16, November 23, October 27, September 30, July 29, June 30, May 23, March 18, January 21, 2011; December 22, October 15, September 10, August 11, June 1, May 21, April 14, February 8, 2010; December 15, October 23, September 25, August 11, July 1, May 20, April 17, March 11, February 27, January 23, 2009; University of Utah, Drug Information Service. Copyright 2015, 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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