Irbesartan Tablets Shortage

• • 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, 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 31722-0731-90
  • 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, 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, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0278-03
  • 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 43547-0279-03
  • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0279-09
  • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0279-50
  • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 500 count, NDC 43547-0376-50
  • 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, 500 count, NDC 43547-0277-50
  • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 500 count, NDC 43547-0374-50
  • Irbesartan oral tablet, Winthrop, 150 mg, bottle, 90 count, NDC 00955-1041-90
  • Irbesartan oral tablet, Winthrop, 300 mg, bottle, 90 count, NDC 00955-1042-90
  • Irbesartan oral tablet, Winthrop, 75 mg, bottle, 90 count, NDC 00955-1040-90

• • Alembic has irbesartan available in 30 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 did not provide a reason for the shortage.
  • Lupin has discontinued irbesartan tablets.
  • Hikma and Westminster are not actively marketing irbesartan tablets.
  • MacLeod's has irbesartan tablets available to contracted customers only.
  • Sanofi-Aventis was not able to provide information on the availability of Avapro tablets.
  • Solco and ScieGen were affected by the recall.
  • Winthrop did not provide a reason for the shortage.
  • Repackagers may have some presentations affected depending on the source supplier.

• • 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, 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, 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

• • Camber has irbesartan tablets on allocation.
  • Solco has several irbesartan 75 mg, 150 mg, and 300 mg tablets on back order and the company cannot estimate a release date.
  • Sanofi Aventis has Avapro 75 mg, 150 mg, and 300 mg tablets available with short expiration dating.
  • Winthrop has irbesartan 75 mg, 150 mg, and 300 mg tablets on allocation.