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Acetylcysteine Inhalation Solution

[06 June 2014]

Products Affected - Description

Acetylcysteine inhalation solution, American Regent
100 mg/mL, 4 mL (NDC 00517-7504-25)
100 mg/mL, 10 mL (NDC 00517-7510-03)
200 mg/mL, 4 mL (NDC 00517-7604-25)
200 mg/mL, 10 mL (NDC 00517-7610-03)
200 mg/mL, 30 mL (NDC 00517-7630-03)
 
Acetylcysteine inhalation solution, Hospira
100 mg/mL, 30 mL (NDC 00409-3307-03)
200 mg/mL, 30 mL (NDC 00409-3308-03)
 
Acetylcysteine inhalation solution, Roxane Labs 
100 mg/mL, 10 mL (NDC 00054-3027-02) - discontinued 
100 mg/mL, 30 mL (NDC 00054-3025-02) - discontinued
200 mg/mL, 10 mL (NDC 00054-3028-02) - discontinued 
200 mg/mL, 30 mL (NDC 00054-3026-02) - discontinued

Reason for the Shortage

  • American Regent had temporarily suspended distribution of most drug products in April, 2011.
  • American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
  • Roxane Labs discontinued acetylcysteine inhalation solution in April 2014. The product had previously been on shortage due to manufacturing delays.
  • Hospira has acetylcysteine inhalation solution on shortage due to manufacturing delay.
  • Fresenius Kabi (formerly APP) states the reason for the shortage was increased demand.

Available Products

Acetylcysteine inhalation solution, Fresenius Kabi
200 mg/mL, 4 mL (NDC 63323-0694-04)
200 mg/mL, 10 mL (NDC 63323-0692-10)
200 mg/mL, 30 mL (NDC 63323-0690-30)

Estimated Resupply Dates

  • American Regent has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date.
  • Hospira has all acetylcysteine inhalation solution presentations on back order and the company estimates a release date of August 2014.

Updated

June 6, 2014; May 27, 2014; May 7, 2014; April 11, 2014; April 9, 2014; April 8, 2014; March 10, 2014; February 7, 2014; January 7, 2014; December 27, 2013; November 27, 2013; November 5, 2013; October 18, 2013; October 4, 2013; October 3, 2013; September 16, 2013; September 3, 2013; July 17, 2013; July 2, 2013; June 14, 2013; May 24, 2013; May 10, 2013; April 17, 2013; April 1, 2013; February 27, 2013; January 21, 2013; December 31, 2012; December 26, 2012; November 28, 2012; October 22, 2012; September 25, 2012; August 23, 2012; July 10, 2012; June 5, 2012; May 22, 2012; May 1, 2012; April 11, 2012; March 9, 2012; January 18, 2012; December 14, 2011; November 8, 2011; September 7, 2011; August 26, 2011; August 15, 2011; August 8, 2011; June 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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