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Acetylcysteine Inhalation Solution

[08 June 2015]

Products Affected - Description

Acetylcysteine solution, American Regent
100 mg/mL, 4 mL vial, 25 count (NDC 00517-7504-25)
100 mg/mL, 10 mL vial, 3 count (NDC 00517-7510-03)
200 mg/mL, 10 mL vial, 3 count (NDC 00517-7610-03)
 

Reason for the Shortage

  • American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
  • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
  • Hospira had acetylcysteine oral and inhalation solution on shortage due to manufacturing delay.
  • Fresenius Kabi states the reason for the shortage was increased demand.

Available Products

Acetylcysteine solution, American Regent
200 mg/mL, 4 mL vial, 25 count (NDC 00517-7604-25)
200 mg/mL, 30 mL vial, 3 count (NDC 00517-7630-03)
 
Acetylcysteine solution, Fresenius Kabi
200 mg/mL, 4 mL vial, 25 count (NDC 63323-0694-04)

200 mg/mL, 10 mL vial, 3 count (NDC 63323-0692-10)
200 mg/mL, 30 mL vial, 3 count (NDC 63323-0690-30)
 
Acetylcysteine solution, Hospira
100 mg/mL, 30 mL vial, 3 count (NDC 00409-3307-03)
200 mg/mL, 30 mL vial, 3 count (NDC 00409-3308-03)

Estimated Resupply Dates

American Regent has acetylcysteine oral and inhalation solution 100 mg/mL 4 mL and 10 mL vials available with an expiration date of October 2015. The 200 mg/mL 10 mL are on back order and the company cannot estimate a release date.

Related Shortages

Updated

June 8, May 15, April 10, March 23, February 23, January 16, 2015; December 3, October 23, August 18, June 6, May 7 and 27, April 8, 9 and 11, March 10, February 7, January 7, 2014; December 27, November 5 and 27, October 3, 4, and 18, September 3 and 16, July 2 and 17, June 14, May 10 and 24, April 1 and 17, February 27, and January 21, 2013; December 26 and 31, November 28, October 22, September 25, August 23, July 10, June 5, May 1 and 22, April 11, March 9, and January 18, 2012; December 14, November 8, October 4, September 7, August 8, 15, and 26, June 28, 2011 University of Utah, Drug Information Service. Copyright 2015, 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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