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1/21/2020

Acetylcysteine Oral and Inhalation Solution

Products Affected - Description

    • Cetylev oral effervescent tablet, Arbor, 2.5 gram, packet, 20 count, NDC 24338-0725-10 - discontinued
    • Cetylev oral effervescent tablet, Arbor, 500 mg, packet, 20 count, NDC 24338-0700-10 - discontinued
    • Acetylcysteine solution, American Regent, 200 mg/mL, 30 mL vial, 3 count, NDC 00517-7630-03
    • 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.
    • Arbor discontinued Cetylev effervescent tablets in April 2019.
    • Fresenius Kabi has acetylcysteine oral and inhalation solution available.
    • 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, 30 mL vial, 3 count, NDC 63323-0691-30
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 4 mL vial, 25 count, NDC 63323-0695-04
    • 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, Fresenius Kabi, 200 mg/mL, 4 mL vial, 3 count, NDC 63323-0694-04
    • Acetylcysteine solution, Pfizer, 100 mg/mL, 30 mL vial, 3 count, NDC 00409-3307-03

Estimated Resupply Dates

    • American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company cannot estimate a release date.
    • Pfizer has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company estimates a release date of February 2020.

Updated

Updated January 21, 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

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