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Ketorolac Tromethamine Injection

[16 October 2014]

Products Affected - Description

Ketorolac Injection, Fresenius Kabi
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)
30 mg/mL 1 mL vials, 25 count (NDC 00409-3795-01)
30 mg/mL 2 mL vials for intramuscular use, 10 count (NDC 00409-3796-01)
 
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, Ben Venue (formerly Bedford product)
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 is 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 closed in early 2014. 
  • 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
15 mg/mL 1 mL vial, 25 count (NDC 63323-0161-01)
 
Ketorolac Injection, Hospira
15 mg/mL 1 mL vial, 25 count (NDC 00409-3793-01)
30 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2287-31)
30 mg/mL 1 mL iSecure Luer Lock syringe, 10 count (NDC 00409-2287-23)
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

  • Fresenius Kabi has ketorolac 30 mg/mL 1 mL vials and 30 mg/mL 2 mL vials for intramuscular injection available on allocation and the products have short expiration dating (< 9 months).
  • West-Ward has all ketorolac injection presentations on back order and the company cannot estimate a release date for these products.
  • Hospira has ketorolac 15 mg/mL 1 mL Carpuject syringes on back order and the company cannot estimate a release date. Ketorolac 30 mg/mL 1 mL vials are on back order with an estimated release date in early-November 2014. Ketorolac 30 mg/mL 2 mL vials for intramuscular injection are on back order with an estimated release date in late-October 2014.
  • Wockhardt has all ketorolac injection presentations on back order and the company cannot estimate a release date.

Related Shortages

Updated

October 16, 2014; August 8, 2014; 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; May 28, 2013; April 5, 2013; March 7, 2013; February 7, 2013; January 23, 2013; January 18, 2013; December 21, 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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