[14 June 2013]
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, APP
200 mg/mL, 30 mL (NDC 63323-0690-30)
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)
100 mg/mL, 30 mL (NDC 00054-3025-02)
200 mg/mL, 10 mL (NDC 00054-3028-02)
200 mg/mL, 30 mL (NDC 00054-3026-02)
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 has acetylcysteine inhalation solution on shortage due to manufacturing delays.
- Hospira has acetylcysteine inhalation solution on shortage due to increased demand for the product.
- APP could not provide a reason for the shortage.
No presentations are readily available.
Estimated Resupply Dates
- American Regent has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date.
- APP has acetylcysteine inhalation solution in 200 mg/mL 30 mL vials on intermittent back order and the company is releasing product as it becomes available.
- Hospira has acetylcysteine inhalation solution 100 mg/mL 30 mL vials and 200 mg/mL 30 mL vials on back order with an estimated release date of June 2013.
- Roxane Labs has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date.
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 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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