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Acetylcysteine Oral and Inhalation Solution

[11 April 2016]

Products Affected - Description

Acetylcysteine solution, American Regent
100 mg/mL, 10 mL vial, 3 count (NDC 00517-7510-03)
200 mg/mL, 10 mL vial, 3 count (NDC 00517-7610-03)
 
Acetylcysteine solution, Fresenius Kabi
100 mg/mL, 10 mL vial, 3 count (NDC 63323-0693-10)
100 mg/mL, 30 mL vial, 3 count (NDC 63323-0691-30)
200 mg/mL, 4 mL vial, 3 count (NDC 63323-0694-04)
200 mg/mL, 10 mL vial, 3 count (NDC 63323-0692-10)

Reason for the Shortage

  • American Regent has a consistent supply of acetylcysteine oral and inhalation solution.
  • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
  • Hospira states the reason for the shortage was manufacturing delay.
  • Fresenius Kabi states the reason for the shortage is manufacturing delays.

Available Products

Acetylcysteine solution, American Regent
100 mg/mL, 4 mL vial, 25 count (NDC 00517-7504-25)
200 mg/mL, 4 mL vial, 3 count (NDC 00517-7604-25)
200 mg/mL, 30 mL vial, 3 count (NDC 00517-7630-03)
 
Acetylcysteine solution, Fresenius Kabi
100 mg/mL, 4 mL vial, 25 count (NDC 63323-0695-04)
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 solution 100 mg/mL 10 mL vials on back order and the company cannot estimate a release date. Acetylcysteine 200 mg/mL 10 mL vials are available with a short expiration date (September 2016).
  • Fresenius Kabi has acetylcysteine solution 100 mg/mL 10 mL vials on back order and the company estimates a release date in mid- to late-April 2016. Fresenius Kabi has acetylcysteine 200 mg/mL 4 mL vials and 10 mL vials, and 100 mg/mL 30 mL vials on back order and the company cannot estimate a release date.

Related Shortages

Updated

April 11, February 24, January 12, 2016; December 3, November 16, October 15 and 1, September 4, July 16, June 8, May 15, April 10, March 23, January 16, 2015; December 3, October 23, August 18, June 6, May 27 and 7, April 11, 9 and 8, March 10, February 7, 2014; December 27, November 5, October 18, 4 and 3, September 16 and 3, July 17 and 2, June 14, May 24 and 10, April 17 and 1, February 27, January 21, 2013; December 31 and 26, November 28, October 22, September 25, August 23, July 10, June 5, May 22 and 1, April 11, March 9, January 18, 2012; December 14, November 8, October 4, September 7, August 26, 15 and 8, June 28, 2011, University of Utah, Drug Information Service. Copyright 2016, 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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