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7/29/2022

Valsartan and Hydrochlorothiazide Tablets

Products Affected - Description

    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/25 mg, bottle, 500 count, NDC 00378-6323-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/12.5 mg, bottle, 500 count, NDC 00378-6324-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/25 mg, bottle, 500 count, NDC 00378-6325-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 80 mg/12.5 mg, bottle, 500 count, NDC 00378-6321-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 160 mg/12.5 mg, bottle, 90 count, NDC 43547-0312-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 160 mg/25 mg, bottle, 90 count, NDC 43547-0313-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 320 mg/12.5 mg, bottle, 90 count, NDC 43547-0314-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 320 mg/25 mg, bottle, 90 count, NDC 43547-0315-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 80 mg/12.5 mg, bottle, 90 count, NDC 43547-0311-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 160 mg/12.5 mg, bottle, 90 count, NDC 00591-2316-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 160 mg/25 mg, bottle, 90 count, NDC 00591-2317-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 320 mg/12.5 mg, bottle, 90 count, NDC 00591-2318-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 320 mg/25 mg, bottle, 90 count, NDC 00591-2319-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 80 mg/12.5 mg, bottle, 90 count, NDC 00591-2315-19 - discontinued

Reason for the Shortage

    • Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.
    • Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.
    • Alembic has valsartan/hydrochlorothiazide tablets available.
    • Aurobindo refused to provide updated availability information.
    • Lupin has not provided recent availability updates.
    • Macleods has valsartan/hydrochlorothiazide tablets available.
    • Mylan discontinued valsartan/hydrochlorothiazide tablet presentations in 500 count bottles in June 2021.
    • Repackagers may have some presentations affected depending on the source supplier.

Available Products

    • Diovan HCT oral tablet, Novartis, 160 mg/12.5 mg, bottle, 90 count, NDC 00078-0315-34
    • Diovan HCT oral tablet, Novartis, 160 mg/25 mg, bottle, 90 count, NDC 00078-0383-34
    • Diovan HCT oral tablet, Novartis, 320 mg/12.5 mg, bottle, 90 count, NDC 00078-0471-34
    • Diovan HCT oral tablet, Novartis, 80 mg/12.5 mg, bottle, 90 count, NDC 00078-0314-34
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/12.5 mg, bottle, 90 count, NDC 62332-0080-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/12.5 mg, bottle, 500 count, NDC 62332-0080-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/25 mg, bottle, 90 count, NDC 62332-0081-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/25 mg, bottle, 500 count, NDC 62332-0081-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/12.5 mg, bottle, 90 count, NDC 62332-0082-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/12.5 mg, bottle, 500 count, NDC 62332-0082-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/25 mg, bottle, 90 count, NDC 62332-0083-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/25 mg, bottle, 500 count, NDC 62332-0083-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 80 mg/12.5 mg, bottle, 90 count, NDC 62332-0079-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 80 mg/12.5 mg, bottle, 500 count, NDC 62332-0079-71
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/12.5 mg, bottle, 90 count, NDC 68180-0104-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/12.5 mg, bottle, 500 count, NDC 68180-0104-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/25 mg, bottle, 90 count, NDC 68180-0105-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/12.5 mg, bottle, 90 count, NDC 68180-0101-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/12.5 mg, bottle, 500 count, NDC 68180-0101-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/25 mg, bottle, 90 count, NDC 68180-0102-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/25 mg, bottle, 500 count, NDC 68180-0102-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 80 mg/12.5 mg, bottle, 90 count, NDC 68180-0103-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 80 mg/12.5 mg, bottle, 500 count, NDC 68180-0103-02
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/12.5 mg, bottle, 90 count, NDC 33342-0075-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/12.5 mg, bottle, 500 count, NDC 33342-0075-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/25 mg, bottle, 90 count, NDC 33342-0076-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/25 mg, bottle, 500 count, NDC 33342-0076-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/12.5 mg, bottle, 90 count, NDC 33342-0077-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/12.5 mg, bottle, 500 count, NDC 33342-0077-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/25 mg, bottle, 90 count, NDC 33342-0078-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/25 mg, bottle, 500 count, NDC 33342-0078-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 80 mg/12.5 mg, bottle, 80 count, NDC 33342-0074-44
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 80 mg/12.5 mg, bottle, 90 count, NDC 33342-0074-10
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/12.5 mg, bottle, 90 count, NDC 00378-6322-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/25 mg, bottle, 90 count, NDC 00378-6323-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/12.5 mg, bottle, 90 count, NDC 00378-6324-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/25 mg, bottle, 90 count, NDC 00378-6325-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 80 mg/12.5 mg, bottle, 90 count, NDC 00378-6321-77

Updated

Updated July 29, 2022 by Anthony Trovato, PharmD, BCPS. Created July 17, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, 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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