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7/17/2019

Losartan Tablets

Products Affected - Description

    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 30 count, NDC 59746-0335-30
    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 90 count, NDC 59746-0335-90
    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 1000 count, NDC 59746-0335-10
    • Losartan potassium oral tablet, Cadista, 25 mg, bottle, 90 count, NDC 59746-0333-90
    • Losartan potassium oral tablet, Cadista, 25 mg, bottle, 1000 count, NDC 59746-0333-10
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 30 count, NDC 59746-0334-30
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 90 count, NDC 59746-0334-90
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 1000 count, NDC 59746-0334-10
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 30 count, NDC 31722-0702-30
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 90 count, NDC 31722-0702-90
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 1000 count, NDC 31722-0702-10
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 90 count, NDC 31722-0700-90
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 500 count, NDC 31722-0700-05
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 1000 count, NDC 31722-0700-10
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 30 count, NDC 31722-0701-30
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 90 count, NDC 31722-0701-90
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 1000 count, NDC 31722-0701-10
    • Losartan potassium oral tablet, Heritage, 100 mg, bottle, 30 count, NDC 23155-0646-03
    • Losartan potassium oral tablet, Heritage, 100 mg, bottle, 90 count, NDC 23155-0646-09
    • Losartan potassium oral tablet, Heritage, 100 mg, bottle, 1000 count, NDC 23155-0646-10
    • Losartan potassium oral tablet, Heritage, 25 mg, bottle, 30 count, NDC 23155-0644-03
    • Losartan potassium oral tablet, Heritage, 25 mg, bottle, 90 count, NDC 23155-0644-09
    • Losartan potassium oral tablet, Heritage, 25 mg, bottle, 1000 count, NDC 23155-0644-10
    • Losartan potassium oral tablet, Heritage, 50 mg, bottle, 30 count, NDC 23155-0645-03
    • Losartan potassium oral tablet, Heritage, 50 mg, bottle, 90 count, NDC 23155-0645-09
    • Losartan potassium oral tablet, Heritage, 50 mg, bottle, 1000 count, NDC 23155-0645-10
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 90 count, NDC 68180-0212-09
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 90 count, NDC 68180-0378-09
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 1000 count, NDC 68180-0212-03
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 1000 count, NDC 68180-0378-03
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 90 count, NDC 68180-0210-09
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 90 count, NDC 68180-0376-09
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 1000 count, NDC 68180-0376-03
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 1000 count, NDC 68180-0210-03
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 90 count, NDC 68180-0211-09
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 90 count, NDC 68180-0377-09
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 1000 count, NDC 68180-0211-03
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 1000 count, NDC 68180-0377-03
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 100 mg, bottle, 1000 count, NDC 57237-0206-99
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 25 mg, bottle, 90 count, NDC 57237-0204-90
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 25 mg, bottle, 1000 count, NDC 57237-0204-99
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 50 mg, bottle, 90 count, NDC 57237-0205-90
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 50 mg, bottle, 1000 count, NDC 57237-0205-99
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 30 count, NDC 00781-5702-31
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 90 count, NDC 00781-5702-92
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 1000 count, NDC 00781-5702-10
    • Losartan potassium oral tablet, Sandoz, 25 mg, bottle, 90 count, NDC 00781-5700-92
    • Losartan potassium oral tablet, Sandoz, 25 mg, bottle, 1000 count, NDC 00781-5700-10
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 30 count, NDC 00781-5701-31
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 90 count, NDC 00781-5701-92
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 1000 count, NDC 00781-5701-10
    • Losartan potassium oral tablet, Teva, 100 mg, bottle, 1000 count, NDC 00591-3747-10
    • Losartan potassium oral tablet, Teva, 25 mg, bottle, 1000 count, NDC 00591-3745-10
    • Losartan potassium oral tablet, Teva, 50 mg, bottle, 1000 count, NDC 00591-3746-10
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 30 count, NDC 68382-0137-06
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 90 count, NDC 68382-0137-16
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 1000 count, NDC 68382-0137-10
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 30 count, NDC 68382-0135-06
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 90 count, NDC 68382-0135-16
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 1000 count, NDC 68382-0135-10
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 30 count, NDC 68382-0136-06
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 90 count, NDC 68382-0136-16
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 1000 count, NDC 68382-0136-10

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.
    • Camber, Heritage, Teva, and Torrent been affected by the recall.
    • Alembic has losartan tablets available.
    • Aurobindo and Mylan refuse to provide updated availability information.
    • Cadista states the reason for their shortage is issues with obtaining active ingredient.
    • Camber has unaffected lots on allocation to contracted customers.
    • Lupin, Rising, Sandoz, and Zydus did not provide a reason for the shortage.
    • Major has losartan tablets in unit-dose packages available.
    • Merck has Cozaar available.
    • Torrent recalled several lots of losartan tablet presentations due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.
    • Torrent has been unavailable to provide updated availability information.

Available Products

    • Cozaar oral tablet, Merck, 100 mg, bottle, 30 count, NDC 00006-0960-31
    • Cozaar oral tablet, Merck, 100 mg, bottle, 90 count, NDC 00006-0960-54
    • Cozaar oral tablet, Merck, 25 mg, bottle, 90 count, NDC 00006-0951-54
    • Cozaar oral tablet, Merck, 50 mg, bottle, 30 count, NDC 00006-0952-31
    • Cozaar oral tablet, Merck, 50 mg, bottle, 90 count, NDC 00006-0952-54
    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 30 count, NDC 62332-0029-30
    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 90 count, NDC 62332-0029-90
    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 1000 count, NDC 62332-0029-91
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 30 count, NDC 62332-0027-30
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 90 count, NDC 62332-0027-90
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 1000 count, NDC 62332-0027-91
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 30 count, NDC 62332-0028-30
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 90 count, NDC 62332-0028-90
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 1000 count, NDC 62332-0028-91
    • Losartan potassium oral tablet, Major, 100 mg, unit-dose blister pack, 100 count, NDC 00904-6389-61
    • Losartan potassium oral tablet, Major, 25 mg, unit-dose blister pack, 100 count, NDC 00904-6391-61
    • Losartan potassium oral tablet, Major, 50 mg, unit-dose blister pack, 100 count, NDC 00904-6390-61

Estimated Resupply Dates

    • Cadista has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Camber has all losartan potassium tablets on allocation.
    • Heritage has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Lupin has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Sandoz has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Teva has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Zydus has losartan potassium tablets on allocation.

Updated

Updated July 17, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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