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6/22/2020

Acetylcysteine Oral and Inhalation Solution

Products Affected - Description

    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 30 mL vial, 3 count, NDC 63323-0691-30
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 10 mL vial, 3 count, NDC 63323-0692-10
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 30 mL vial, 3 count, NDC 63323-0690-30
    • Acetylcysteine solution, Pfizer, 100 mg/mL, 30 mL vial, 3 count, NDC 00409-3307-03
    • Acetylcysteine solution, Pfizer, 200 mg/mL, 30 mL vial, 3 count, NDC 00409-3308-03

Reason for the Shortage

    • American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. They are not currently marketing the 200 mg/mL 30 mL vials.
    • Arbor discontinued Cetylev effervescent tablets in April 2019.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Available Products

    • Acetylcysteine solution, American Regent, 100 mg/mL, 4 mL vial, 25 count, NDC 00517-7504-25
    • Acetylcysteine solution, American Regent, 200 mg/mL, 4 mL vial, 3 count, NDC 00517-7604-25
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 10 mL vial, 3 count, NDC 63323-0693-10
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 4 mL vial, 25 count, NDC 63323-0695-04
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 4 mL vial, 3 count, NDC 63323-0694-04

Estimated Resupply Dates

    • Pfizer has acetylcysteine solution 100 mg/mL 10 mL and 30 mL vials available in limited supply.
    • Fresenius Kabi has acetylcysteine solution 200 mg/mL 10 mL and 30 mL vials on back order and the company estimates a release date of late-June to early-July 2020 for the 10 mL vials and mid-July 2020 for the 30 mL vials. The 100 mg/mL 30 mL vials are on back order and the company estimates a release date of late-June to early-July 2020.

Updated

Updated June 22, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 28, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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