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2/14/2020

Irbesartan Tablets

Products Affected - Description

    • 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, 150 mg, bottle, 500 count, NDC 62332-0042-71
    • 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, 300 mg, bottle, 500 count, NDC 62332-0043-71
    • 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, 150 mg, bottle, 1000 count, NDC 31722-0161-10
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 30 count, NDC 31722-0731-30
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0731-90
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0162-05
    • 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, Camber, 75 mg, bottle, 500 count, NDC 31722-0160-05
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 30 count, NDC 68180-0411-06
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 90 count, NDC 68180-0411-09
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 30 count, NDC 59746-0449-30
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 90 count, NDC 59746-0449-90
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 30 count, NDC 68180-0410-06
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 90 count, NDC 68180-0410-09
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0278-03
    • 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 43547-0278-09
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 500 count, NDC 43547-0278-50
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 500 count, NDC 43547-0375-50
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0376-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0279-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0279-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0376-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0376-50
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0279-50
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0374-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0277-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0277-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0374-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 500 count, NDC 43547-0374-50
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 500 count, NDC 43547-0277-50
    • Irbesartan oral tablet, Westminster, 150 mg, bottle, 30 count, NDC 69367-0120-01
    • Irbesartan oral tablet, Westminster, 150 mg, bottle, 90 count, NDC 69367-0120-03
    • Irbesartan oral tablet, Westminster, 300 mg, bottle, 30 count, NDC 69367-0121-01
    • Irbesartan oral tablet, Westminster, 300 mg, bottle, 90 count, NDC 69367-0121-03
    • Irbesartan oral tablet, Westminster, 75 mg, bottle, 30 count, NDC 69367-0119-01
    • Irbesartan oral tablet, Westminster, 75 mg, bottle, 90 count, NDC 69367-0119-03

Reason for the Shortage

    • 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.
    • Solco and ScieGen were affected by the recall.
    • Camber, Lupin, and Westminster did not provide a reason for the shortage.
    • Hikma is not actively marketing irbesartan tablets.
    • MacLeod's has irbesartan tablets available to contracted customers only.
    • Sanofi-Aventis has Avapro tablets available.
    • Repackagers may have some presentations affected depending on the source supplier.

Available Products

    • Avapro oral tablet, Sanofi-Aventis, 150 mg, bottle, 30 count, NDC 00024-585-30
    • Avapro oral tablet, Sanofi-Aventis, 300 mg, bottle, 30 count, NDC 00024-5852-30
    • Avapro oral tablet, Sanofi-Aventis, 300 mg, bottle, 90 count, NDC 00024-5852-90
    • Avapro oral tablet, Sanofi-Aventis, 75 mg, bottle, 90 count, NDC 00024-5850-90
    • 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

Estimated Resupply Dates

    • Alembic has irbesartan 75 mg tablets in 30-count bottles and 300 mg tablets in 90- and 500-count bottles on back order and the company cannot estimate a release date. All other tablet presentations are on intermittent back order and the company is releasing drug as it becomes available.
    • Camber has irbesartan tablets on allocation.
    • Lupin has irbesartan tablets on allocation.
    • Solco has irbesartan tablets on long-term back order and the company cannot estimate a release date.
    • Westminster has irbesartan tablets on back order and the company cannot estimate a release date.

Updated

Updated February 14, 2020 by Anthony Trovato, PharmD, BCPS. Created July 19, 2019 by Leslie Jensen, 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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