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1/18/2023

Valsartan Tablets

Products Affected - Description

    • 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

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.
    • Alembic has valsartan tablets available.
    • Archis Pharma has valsartan tablets available.
    • Aurobindo refuses to provide availability information.
    • Cadista has discontinued valsartan tablets.
    • Camber has temporarily discontinued valsartan tablets.
    • Lupin is not actively marketing valsartan tablets.
    • MacLeods has valsartan tablets available.
    • Viatris has valsartan tablets available.
    • 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, 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, Archis Pharma, 160 mg, bottle, 90 count, NDC 72819-0183-09
    • Valsartan oral tablet, Archis Pharma, 320 mg, bottle, 90 count, NDC 72819-0184-09
    • Valsartan oral tablet, Archis Pharma, 40 mg, bottle, 30 count, NDC 72819-0181-03
    • Valsartan oral tablet, Archis Pharma, 80 mg, bottle, 90 count, NDC 72819-0182-09
    • 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 (Viatris), 160 mg, bottle, 90 count, NDC 00378-5814-77
    • Valsartan oral tablet, Mylan (Viatris), 320 mg, bottle, 90 count, NDC 00378-5815-77
    • Valsartan oral tablet, Mylan (Viatris), 40 mg, bottle, 30 count, NDC 00378-5807-93
    • Valsartan oral tablet, Mylan (Viatris), 80 mg, bottle, 90 count, NDC 00378-5813-77

Estimated Resupply Dates

    • Most marketed presentations are available.

Safety

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

Updated

Updated January 18, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created July 17, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, 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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