[14 June 2013]
Products Affected - Description
Ketorolac Injection, 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)
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, Hospira
15 mg/mL 1 mL vial, 25 count (NDC 00409-3793-01)
15 mg/mL 1 mL Novaplus vial, 25 count (NDC 00409-3793-49)
30 mg/mL 1 mL vials, 25 count (NDC 00409-3795-01)
30 mg/mL 2 mL Carpuject syringe for intramuscular use, 10 count (NDC 00409-2287-61)
30 mg/mL 2 mL vials, 10 count (NDC 00409-3796-01)
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.
- APP states the shortage is due to manufacturing delays.
- Baxter and Wockhardt 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 voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis. Product is becoming available in stages as production resumes. Availability of products is updated on the Bedford Laboratories website.
- 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, APP
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 Carpuject syringe, 10 count (NDC 00409-2287-31)
30 mg/mL 1 mL Novaplus vial, 25 count (NDC 00409-3795-49)
30 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2287-31)
30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00409-3796-49)
Ketorolac Injection, Wockhardt
30 mg/mL 2 mL vial, 10 count (NDC 64679-0758-06)
30 mg/mL 2 mL vial, 25 count (NDC 64679-0758-02)
Estimated Resupply Dates
- APP has ketorolac 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order and the company estimates a release date in early-July 2013.
- West-Ward has all ketorolac injection presentations on back order and the company cannot estimate a release date for these products.
- Bedford has all ketorolac injection presentations on long-term back order and will not be manufactured until capacity permits.
- Wockhardt has all ketorolac injection presentations on back order and the company cannot estimate a release date.
- Hospira has ketorolac 15 mg/mL 1 mL vials in 25 count, 30 mg/mL latex free vials, and 30 mg/mL 2 mL vials and 2 mL Carpuject syringes for intramuscular use on back order with an estimated release date in mid-June, 2013. Ketorolac 15 mg/mL 1 mL Novaplus vials are on allocation.
Related Shortages
Updated
June 14, 2013; June 13, 2013; May 28, 2013; April 5, 2013; March 7, 2013; February 7, 2013; January 23, 2013; January 18, 2013; January 8, 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; April 6, 2012; March 20, 2012; March 8, 2012; February 22, 2012; February 3, 2012; January 11, 2012; December 21, 2011; December 14, 2011; November 23, 2011; November 11, 2011; October 19, 2011; October 6, 2011; August 26, 2011; August 17, 2011; August 15, 2011; July 15, 2011; June 30, 2011; June 24, 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 2013, 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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