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Irbesartan Tablets Shortage

Last Updated: December 7, 2024
Status: Current

Products Affected - Description
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 30 count, NDC 68180-0411-06 - discontinued
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 90 count, NDC 68180-0411-09 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 30 count, NDC 59746-0449-30 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 90 count, NDC 59746-0449-90 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 30 count, NDC 68180-0410-06 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 90 count, NDC 68180-0410-09 - discontinued
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 30 count, NDC 33342-0048-07
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 90 count, NDC 33342-0048-10
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 30 count, NDC 33342-0049-07
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 90 count, NDC 33342-0049-10
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 30 count, NDC 33342-0047-07
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 90 count, NDC 33342-0047-10
    • Irbesartan oral tablet, Winthrop, 150 mg, bottle, 90 count, NDC 00955-1041-90 - discontinued
    • Irbesartan oral tablet, Winthrop, 300 mg, bottle, 90 count, NDC 00955-1042-90 - discontinued
    • Irbesartan oral tablet, Winthrop, 75 mg, bottle, 90 count, NDC 00955-1040-90 - discontinued
Reason for the Shortage
    • Alembic has irbesartan available in 30 count and 90 count presentations.
    • Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.
    • Camber has irbesartan tablets available.
    • Lupin has discontinued irbesartan tablets.
    • Hikma and Westminster are not actively marketing irbesartan tablets.
    • MacLeod's has irbesartan tablets on back order and the company cannot estimate a release date.
    • Sanofi-Aventis has Avapro available.
    • Solco has irbesartan available in 30 count and 90 count bottles.
    • Winthrop discontinued irbesartan in December 2023.
    • Repackagers may have some presentations affected depending on the source supplier.
Available Products
    • Avapro oral tablet, Sanofi-Aventis, 150 mg, bottle, 30 count, NDC 00024-5851-30
    • Avapro oral tablet, Sanofi-Aventis, 300 mg, bottle, 30 count, NDC 00024-5852-30
    • Avapro oral tablet, Sanofi-Aventis, 75 mg, bottle, 90 count, NDC 00024-5850-90
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 30 count, NDC 62332-0042-30
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 30 count, NDC 62332-0043-30
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 90 count, NDC 62332-0043-90
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 30 count, NDC 62332-0041-30
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 90 count, NDC 62332-0041-90
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 30 count, NDC 31722-0730-30
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 90 count, NDC 31722-0730-90
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 30 count, NDC 31722-0731-30
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0162-05
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0731-90
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 30 count, NDC 31722-0729-30
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 90 count, NDC 31722-0729-90
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0375-03
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 90 count, NDC 43547-0375-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0376-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0376-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0374-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0374-09

Estimated Resupply Dates

    • Macleods has all presentations on back order and the company cannot estimate a release date.

Updated

Updated December 7, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created July 19, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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