[08 May 2013]
Products Affected - Description
Milrinone injection, APP
1 mg/mL, 20 mL vial (NDC 63323-0617-20)
Milrinone injection, Bedford
1 mg/mL, 10 mL vial (NDC 55390-0019-10)
1 mg/mL, 20 mL vial (NDC 55390-0020-10)
1 mg/mL, 50 mL vial (NDC 55390-0021-10)
0.2 mg/mL, 100 mL premixed bags (NDC 55390-0078-01)
0.2 mg/mL, 200 mL premixed bags (NDC 55390-0079-01)
Milrinone injection, Hospira
0.2 mg/mL, 100 mL premixed bags (NDC 00409-2776-23)
0.2 mg/mL, 200 mL premixed bags (NDC 00409-2776-02)
Milrinone injection, West-Ward
1 mg/mL, 20 mL vial (NDC 00641-6067-10) -
discontinued
1 mg/mL, 10 mL vial (NDC 00641-6065-10) -
discontinued
0.2 mg/mL, 100 mL premixed bags (NDC 00143-9719-10)
0.2 mg/mL, 200 mL premixed bags (NDC 00143-9718-10)
Reason for the Shortage
- APP states the reason for the shortage is increased demand for the product.
- West-Ward cannot provide a reason for the shortage. West-Ward acquired Baxter’s milrinone injection vials in May 2011. NDC codes began changing for these products in early 2012.
- Baxter has milrinone premixed bags on shortage due to increased demand.
- Bedford has milrinone 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.
- Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials.
- Sanofi-Aventis discontinued Primacor injection.
Available Products
Milrinone injection, APP
1 mg/mL, 10 mL vial (NDC 63323-0617-10)
1 mg/mL, 50 mL vial (NDC 63323-0617-50)
Milrinone injection, Baxter
0.2 mg/mL, 100 mL premixed bags, NDC 00338-6010-48
0.2 mg/mL, 200 mL premixed bags, NDC 00338-6011-37
Milrinone injection, West-Ward
1 mg/mL, 10 mL vial (NDC 00143-9710-10)
1 mg/mL, 20 mL vial (NDC 00143-9709-10)
1 mg/mL, 50 mL vial (NDC 00143-9708-01)
Estimated Resupply Dates
- APP has milrinone 1 mg/mL 20 mL vials on back order with an estimated release date of early-June 2013.
- Bedford has milrinone 1 mg/mL 10 mL, 20 mL and 50 mL vials, and 0.2 mg/mL 100 mL and 200 mL premixes on back order and the company cannot estimate a release date.
- Hospira has milrinone 0.2 mg/mL 100 mL and 200 mL premixes on back order and the company estimates a release date of June 2013 for the 100 mL premix and May 2013 for the 200 mL premix.
- West-Ward has milrinone 0.2 mg/mL 100 mL premix on back order and the company cannot estimate a release date. The 200 mL premix is available in very limited supply.
Related Shortages
Updated
May 8, 2013; April 19, 2013; April 1, 2013; February 7, 2013; December 12, 2012; November 15, 2012; November 7, 2012; October 2, 2012; September 14, 2012; July 26, 2012; July 9, 2012; June 21, 2012; June 4, 2012; May 25, 2012; May 9, 2012; April 27, 2012; April 6, 2012; March 22, 2012; March 2, 2012; February 17, 2012; February 7, 2012; February 1, 2012; January 13, 2012; January 11, 2012; December 22, 2011; December 15, 2011; November 11, 2011; October 27, 2011; October 18, 2011; October 11, 2011; September 23, 2011; September 22, 2011; August 26, 2011; July 29, 2011; June 29, 2011; May 23, 2011; April 28, 2011; April 14, 2011; April 8, 2011; March 23, 2011; March 7, 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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