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5/13/2019

Losartan and Hydrochlorothiazide Tablets

Products Affected - Description

    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0049-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0049-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0049-91
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 30 count, NDC 62332-0050-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 90 count, NDC 62332-0050-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 1000 count, NDC 62332-0050-91
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0048-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0048-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0048-91
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 12.5 mg, bottle, 30 count, NDC 59746-0338-30
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 30 count, NDC 59746-0339-30
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0339-90
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0338-90
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-30
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-90
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0216-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0216-09
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 30 count, NDC 68180-0217-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 90 count, NDC 68180-0217-09
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0215-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0215-09
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0208-90
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0208-99
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 25 mg, bottle, 1000 count, NDC 57237-0209-99
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0207-90
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0207-99
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5204-31
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5207-92
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5204-92
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5204-10
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 30 count, NDC 00781-5207-31
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 1000 count, NDC 00781-5207-10
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5206-31
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5206-92
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5206-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7368-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7368-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7368-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 30 count, NDC 00093-7369-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 90 count, NDC 00093-7369-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 1000 count, NDC 00093-7369-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7367-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7367-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7367-10

Reason for the Shortage

    • Alembic did not provide a reason for the shortage.
    • Aurobindo refused to provide updated availability information
    • Cadista did not provide a reason for the shortage.
    • Lupin did not provide a reason for the shortage.
    • Merck has Hyzaar tablets available.
    • Rising did not provide a reason for the shortage.
    • Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.
    • Torrent recalled certain lots of losartan and hydrochlorothiazide 50 mg/ 12.5 mg tablets in 90 and 1000 count bottles and 100 mg/ 12.5 mg tablets in 90 and 1000 count bottles in December 2018, January 2019, March 2019, and April 2019 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm629693.htm and https://www.fda.gov/Safety/Recalls/ucm636296.htm.
    • Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).
    • Teva did not provide a reason for the shortage.

Available Products

    • Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00006-0745-31
    • Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0745-54
    • Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 30 count, NDC 00006-0747-31
    • Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 90 count, NDC 00006-0747-54
    • Hyzaar oral tablet, Merck, 50 mg /12.5 mg, bottle, 30 count, NDC 00006-0717-31
    • Hyzaar oral tablet, Merck, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0717-54
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0117-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0117-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0117-10
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 30 count, NDC 13668-0118-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 90 count, NDC 13668-0118-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 1000 count, NDC 13668-0118-10
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0116-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0116-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0116-10

Estimated Resupply Dates

    • Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers
    • Cadista has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.
    • Lupin has losartan and hydrochlorothiazide tablets on intermittent back order and the company is allocating supplies as they become available.
    • Rising has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.
    • Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the company cannot estimate a release date.
    • Teva has losartan and hydrochlorothiazide 50 mg/12.5 mg tablets in 30, 90, and 1000 count bottles and 100 mg/12.5 mg tablets in 90 count bottles on back order and the company estimates a release date in early-June 2019. The 100 mg/12.5 mg tablets in 30 count and 1000 count bottles are on back order and the company estimates a release date in late-May 2019. The 100 mg/25 mg tablets in 30, 90, and 1000 count bottles are on back order and the company estimates a release date in late-June 2019.

Updated

Updated May 13, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 11, 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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