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2/5/2020

Valsartan Tablets

Products Affected - Description

    • Valsartan oral tablet, Alembic, 160 mg, bottle, 90 count, NDC 62332-0046-90
    • Valsartan oral tablet, Alembic, 160 mg, bottle, 500 count, NDC 62332-0046-71
    • Valsartan oral tablet, Alembic, 320 mg, bottle, 90 count, NDC 62332-0047-90
    • Valsartan oral tablet, Alembic, 320 mg, bottle, 500 count, NDC 62332-0047-71
    • Valsartan oral tablet, Alembic, 40 mg, bottle, 90 count, NDC 62332-0044-90
    • Valsartan oral tablet, Alembic, 80 mg, bottle, 90 count, NDC 62332-0045-90
    • Valsartan oral tablet, Alembic, 80 mg, bottle, 500 count, NDC 62332-0045-71
    • Valsartan oral tablet, Cadista, 160 mg, bottle, 90 count, NDC 59746-0362-90
    • Valsartan oral tablet, Cadista, 320 mg, bottle, 90 count, NDC 59746-0363-90
    • Valsartan oral tablet, Cadista, 40 mg, bottle, 30 count, NDC 59746-0360-30
    • Valsartan oral tablet, Cadista, 80 mg, bottle, 90 count, NDC 59746-0361-90
    • Valsartan oral tablet, Camber, 160 mg, bottle, 90 count, NDC 31722-0747-90
    • Valsartan oral tablet, Camber, 320 mg, bottle, 90 count, NDC 31722-0748-90
    • Valsartan oral tablet, Camber, 40 mg, bottle, 30 count, NDC 31722-0745-30
    • Valsartan oral tablet, Camber, 80 mg, bottle, 90 count, NDC 31722-0746-90
    • Valsartan oral tablet, Major, 160 mg, unit-dose blister pack, 100 count, NDC 00904-6595-61 - discontinued
    • Valsartan oral tablet, Major, 80 mg, unit-dose blister pack, 100 count, NDC 00904-6594-61 - discontinued
    • Valsartan oral tablet, Mylan, 160 mg, bottle, 90 count, NDC 00378-5814-77
    • Valsartan oral tablet, Mylan, 320 mg, bottle, 90 count, NDC 00378-5815-77
    • Valsartan oral tablet, Solco Healthcare US, 160 mg, bottle, 90 count, NDC 43547-0369-09 - discontinued
    • Valsartan oral tablet, Solco Healthcare US, 320 mg, bottle, 90 count, NDC 43547-0370-09 - discontinued
    • Valsartan oral tablet, Solco Healthcare US, 40 mg, bottle, 30 count, NDC 43547-0367-03 - discontinued
    • Valsartan oral tablet, Solco Healthcare US, 80 mg, bottle, 90 count, NDC 43547-0368-09 - discontinued
    • Valsartan oral tablet, Teva, 160 mg, bottle, 1000 count, NDC 00591-2169-10 - discontinued
    • Valsartan oral tablet, Teva, 320 mg, bottle, 90 count, NDC 00591-2170-19 - discontinued
    • Valsartan oral tablet, Teva, 320 mg, bottle, 500 count, NDC 00591-2170-05 - discontinued
    • Valsartan oral tablet, Teva, 40 mg, bottle, 30 count, NDC 00591-2167-30 - discontinued
    • Valsartan oral tablet, Teva, 40 mg, bottle, 90 count, NDC 00591-2167-19 - discontinued
    • Valsartan oral tablet, Teva, 80 mg, bottle, 90 count, NDC 00591-2168-19 - discontinued
    • Valsartan oral tablet, Teva, 80 mg, bottle, 1000 count, NDC 00591-2168-10 - discontinued

Reason for the Shortage

    • Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.
    • Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.
    • Major, Solco, and Teva discontinued valsartan tablets in July 2018.
    • Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall.
    • Aurobindo, and Macleods refuse to provide updated availability information.
    • Cadista did not provide a reason for the shortage.
    • Lupin is not actively marketing valsartan tablets.
    • Mylan did not provide a reason for the shortage.
    • Repackagers may have some presentations affected depending on the source supplier.

Available Products

    • Diovan oral tablet, Novartis, 160 mg, bottle, 90 count, NDC 00078-0359-34
    • Diovan oral tablet, Novartis, 320 mg, bottle, 90 count, NDC 00078-0360-34
    • Diovan oral tablet, Novartis, 40 mg, bottle, 30 count, NDC 00078-0423-15
    • Diovan oral tablet, Novartis, 80 mg, bottle, 90 count, NDC 00078-0358-34
    • Valsartan oral tablet, Macleods, 160 mg, bottle, 90 count, NDC 33342-0064-10
    • Valsartan oral tablet, Macleods, 320 mg, bottle, 90 count, NDC 33342-0065-10
    • Valsartan oral tablet, Macleods, 40 mg, bottle, 30 count, NDC 33342-0062-07
    • Valsartan oral tablet, Macleods, 80 mg, bottle, 90 count, NDC 33342-0063-10
    • Valsartan oral tablet, Mylan, 40 mg, bottle, 30 count, NDC 00378-5807-93
    • Valsartan oral tablet, Mylan, 80 mg, bottle, 90 count, NDC 00378-5813-77

Estimated Resupply Dates

    • Alembic has valsartan 80 mg tablets on allocation. The 40 mg tablets, 160 mg tablets, and 320 mg tablets are on back order and the company estimates a release date of mid-February 2020.
    • Cadista has all valsartan tablets on back order and the company estimates a release date of late-February 2020 for the 40 mg tablets, early-March 2020 for the 80 mg tablets, and early-April 2020 for the 160 mg and 320 mg tablets.
    • Camber has valsartan tablets on temporary discontinuation and the company cannot estimate a release date.
    • Mylan has valsartan 160 mg and 320 mg tablets on back order and the company estimates a release date of late-February 2020.

Safety

    • Confirm the source of repackaged valsartan products to ensure they are not affected.

Updated

Updated February 5, 2020 by Megan Dryer, PharmD. Created July 17, 2018 by Michelle Wheeler, 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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