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Ondansetron Injection

[09 May 2013]

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)
2 mL iSecure syringe (NDC 00406-1120-12)
20 mL vials (NDC 00409-4759-01)
 
Ondansetron injection, 2 mg/mL, Pfizer
2 mL vials, package of 25 (NDC 00069-1340-16)
 
Ondansetron injection, 2 mg\mL, Wockhardt
20 mL vials (NDC 64679-0727-01) 
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)
 
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
  • Apotex and Cura have discontinued their ondansetron injection.
  • Teva discontinued ondansetron 2 mL vials in 5 count packages.
  • Caraco temporarily discontinued ondansetron injection.
  • West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward discontinued the ondansetron 20 mL vials in October, 2011 and discontinued ondansetron 2 mg/mL vials in packages of 5 in Spring, 2012.
  • Bedford has ondansetron on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.
  • Ben Venue voluntarily entered into a consent decree with FDA  in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.  
  • GlaxoSmithKline has discontinued Zofran 2 mL vials.
  • Hospira has ondansetron on shortage due to manufacturing delays.
  • West-Ward had ondansetron on back order due to increased demand. 
  • Wockhardt could not provide a reason for the shortage.
Ondansetron 32 mg/50 mL premixed bags

  • 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. More information can be found online.
  • 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.
  • 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, APP
2 mL vials, package of 25 (NDC 63323-0373-02)
20 mL multiple dose vials (NDC 63323-0374-20)

Zofran injection, 2 mg/mL, GlaxoSmithKline
20 mL vial (NDC 00173-0442-00)
 
Ondansetron injection, 2 mg/mL, Pfizer
20 mL vials (NDC 00069-1340-02)    
 
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)
20 mL vials (NDC 00703-7226-01)
20 mL vials, packages of 10 (NDC 00703-7226-03)

Ondansetron injection, 2 mg/mL, West-Ward
2 mL vials, packages of 25 (NDC 00143-9891-25)
20 mL vials (NDC 00143-9890-01)

Ondansetron injection, 2 mg/mL, West-Ward (formerly Baxter)
2 mL vials, packages of 25 (NDC 00641-6078-25)
2 mL Novaplus vials, packages of 25 (NDC 00641-6080-25)
20 mL vials (NDC 00641-6079-01)
 
Ondansetron injection, 2 mg\mL, Wockhardt
2 mL vials, packages of 5 (NDC 64679-0726-01)

Ondansetron 32 mg/50 mL premixed bags
No presentations are available.

Estimated Resupply Dates

Ondansetron 2 mg/mL vials
  • Bedford has ondansetron 2 mg/mL 20 mL vials on long-term back order and will not be manufactured until capacity permits.
  • Hospira has ondansetron 2 mg/mL 20 mL vials on back order with an estimated release date of June 2013. The ondansetron 2 mg/mL 2 mL vials are on back order and the company cannot estimate a release date. Hospira has a limited supply available of ondansetron 2 mL iSecure syringes.
  • Pfizer has ondansetron 2 mL vials on back order with an estimated release date of mid-May 2013.
  • Wockhardt has ondansetron 20 mL vials on back order with an estimated release date of mid-May 2013.

Ondansetron 32 mg/50 mL premixed bags

  • Claris has ondansetron 32 mg/50 mL premixed bags on back order and the company cannot estimate a release date.

Related Shortages

Updated

May 9, 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; October 5, 2012; September 19, 2012; September 12, 2012; September 7, 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; April 12, 2012; March 28, 2012; March 27, 2012; March 20, 2012; March 9, 2012; February 29, 2012; February 3, 2012; January 20, 2012; January 13, 2012; December 16, 2011; December 1, 2011; November 23, 2011; November 3, 2011; October 27, 2011; October 12, 2011; September 30, 2011; September 19, 2011; July 29, 2011; June 30, 2011; June 29, 2011; June 24, 2011; May 23, 2011, University of Utah, Drug Information Service. Copyright 2013, 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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