[10 May 2013]
Products Affected - Description
Amiodarone 50 mg/mL injection, APP
9 mL vials, package of 10 (NDC 63323-0616-09)
Amiodarone 50 mg/mL injection, Hospira
3 mL ampules, package of 10 (NDC 00409-4348-35)
3 mL Novaplus ampules, package of 10 (NDC 00409-4348-49)
Amiodarone 50 mg/mL injection, Mylan Institutional
3 mL vials, package of 10 (NDC 67457-0153-03)
9 mL vials, package of 10 (NDC 67457-0153-09)
18 mL vials, package of 1 (NDC 67457-0153-18)
Amiodarone 50 mg/mL injection, Sagent
3 mL syringes (NDC 25021-0302-73) - discontinued
Reason for the Shortage
- Amphastar and Baxter have discontinued amiodarone vials.
- Teva discontinued amiodarone injection in 2010.
- Bedford discontinued all amiodarone presentations in May, 2011 to concentrate on the manufacturing of other products.
- GeneraMedix and Apotex discontinued amiodarone injection some time ago.
- Sagent recalled amiodarone injection in February 2010 and subsequently discontinued amiodarone injection in March 2012.
- Hospira has amiodarone injection on shortage due to manufacturing delays.
- APP has amiodarone injection on shortage due to increased demand.
- West-Ward and Mylan Institutional could not provide a reason for the shortage.
Available Products
Amiodarone 50 mg/mL injection, APP
3 mL vials, package of 10 (NDC 63323-0616-03)
Amiodarone 50 mg/mL injection, West-Ward
3 mL vial, package of 10 (NDC 00143-9875-10)
Nexterone premixed injection, Baxter
150 mg/100 mL premixed bags (NDC 43066-0150-10)
360 mg/200 mL premixed bags (NDC 43066-0360-20)
Estimated Resupply Dates
- APP has amiodarone 50 mg/mL 9 mL vials on intermittent back order and the company is releasing product as it becomes available.
- Hospira has amiodarone 50 mg/mL 3 mL ampules and 3 mL Novaplus ampules on back order and the company estimates a release date of June 2013.
- Mylan Institutional has all amiodarone injection on back order and the company estimates a release date in early-June 2013 for the 9 mL vials. The company cannot estimate a release date for the 3 mL and 18 mL vials.
Related Shortages
Updated
May 10, 2013; April 23, 2013; April 11, 2013; March 28, 2013; March 12, 2013; March 1, 2013; February 5, 2013; January 18, 2013; January 4, 2013; December 12, 2012; November 19, 2012; November 7, 2012; October 22, 2012; October 12, 2012; September 19, 2012; September 5, 2012; August 17, 2012; July 26, 2012; July 13, 2012; June 5, 2012; May 18, 2012; May 2, 2012; April 18, 2012; April 11, 2012; March 30, 2012; March 20, 2012; March 15, 2012; March 1, 2012; January 25, 2012; December 14, 2011; November 16, 2011; Novmeber 3, 2011; October 31, 2011; October 27, 2011; September 21, 2011; August 17, 2011; August 11, 2011; July 14, 2011; June 7, 2011; May 4, 2011; April 22, 2011; March 30, 2011; March 25, 2011; March 10, 2011; March 4, 2011; January 21, 2011, University of Utah, Drug Information Service. Copyright 2013, University of Utah, Drug Information Service.
Disclaimer
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