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Ketorolac Tromethamine Injection

[19 June 2014]

Products Affected - Description

Ketorolac Injection, Hospira
30 mg/mL 1 mL iSecure Luer Lock syringe, 10 count (NDC 00409-2287-23)
 
Ketorolac Injection, West-Ward  
15 mg/mL 1 mL vial, 25 count (NDC 00641-6041-25)
30 mg/mL 1 mL vial, 25 count (NDC 00641-6042-25)
30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00641-6043-25)

Ketorolac Injection, Bedford
15 mg/mL 1 mL vial, 10 count (NDC 55390-0480-01) 
30 mg/mL 1 mL vial, 10 count (NDC 55390-0481-01)
30 mg/mL 10 mL vial, 10 count (NDC 55390-0481-10)
30 mg/mL 2 mL vial for intramuscular use, 10 count (NDC 55390-0481-02)   
 
Ketorolac Injection, Wockhardt
15 mg/mL 1 mL vial, 10 count (NDC 64679-0757-02)
15 mg/mL 1 mL vial, 25 count (NDC 64679-0757-01)
30 mg/mL 1 mL vial, 10 count (NDC 64679-0758-04)
30 mg/mL 1 mL vial, 25 count (NDC 64679-0758-01)
30 mg/mL 1 mL vial, 10 count (NDC 64679-0758-04)

Reason for the Shortage

  • American Regent discontinued all ketorolac injection presentations in 2010.
  • Fresenius Kabi (formerly APP) states the shortage was due to manufacturing delays.
  • Baxter could not provide a reason for the shortage. 
  • Cura filed for bankruptcy in 2010.
  • Hospira has ketorolac on shortage due to manufacturing delays for quality improvement activities and increased demand for the product.
  • 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.West-Ward has ketorolac injection on shortage due to manufacturing delays.
  • West-Ward has ketorolac injection on shortage due to manufacturing delays.
  • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.   

Available Products

Ketorolac Injection, Fresenius Kabi (formerly APP)
15 mg/mL 1 mL vial, 25 count (NDC 63323-0161-01)
30 mg/mL 1 mL vial, 25 count (NDC 63323-0162-01)
30 mg/mL 2 mL vial for intramuscular injection, 25 count (NDC 63323-0162-02)
 
Ketorolac Injection, Hospira
15 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2288-31)
15 mg/mL 1 mL vial, 25 count (NDC 00409-3793-01)
30 mg/mL 1 mL vials, 25 count (NDC 00409-3795-01)
30 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2287-31)
30 mg/mL 1 mL iSecure Leur Lock syringe, 10 count (NDC 00409-2287-23)
30 mg/mL 2 mL vials for intramuscular use, 10 count (NDC 00409-3796-01)  
30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00409-3796-49)
30 mg/mL 2 mL Carpuject syringe for intramuscular use, 10 count (NDC 00409-2287-61)    

Estimated Resupply Dates

  • Hospira has ketorolac 30 mg/mL 1 mL iSecure Luer Lock syringes available on allocation.
  • West-Ward has all ketorolac injection presentations on back order and the company cannot estimate a release date for these products.
  • Bedford has ketorolac injection on long-term back order and the company cannot estimate a release date. Ben Venue manufactured ketorolac for Bedford.
  • Wockhardt has all ketorolac injection presentations on back order and the company cannot estimate a release date.

Related Shortages

Updated

June 19, 2014; May 30, 2014; May 12, 2014; March 20, 2014; January 24, 2014; December 11, 2013; November 4, 2013; October 15, 2013; September 13, 2013; August 6, 2013; July 25, 2013; June 25, 2013; June 14, 2013; May 28, 2013; April 5, 2013; March 7, 2013; February 7, 2013; January 23, 2013; January 18, 2013; December 21, 2012; December 18, 2012; November 30, 2012; October 26, 2012; August 30, 2012; July 3, 2012; June 18, 2012; June 1, 2012; May 11, 2012; April 13, 2012; March 20, 2012; February 22, 2012; February 3, 2012; January 11, 2012; December 21, 2011; November 23, 2011; October 19, 2011; October 6, 2011; August 26, 2011; August 15, 2011; July 15, 2011; June 30, 2011; May 27, 2011; April 15, 2011; April 1, 2011; March 11, 2011; February 17, 2011; February 1, 2011; January 28, 2011, 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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