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Valsartan and Hydrochlorothiazide Tablets

Last Updated: July 29, 2022
Status: Current

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.

Further information

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