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3/4/2020

Tacrolimus Capsules

Products Affected - Description

    • Tacrolimus oral capsule, Accord, 0.5 mg, 100 count, NDC 16729-0041-01 - discontinued
    • Tacrolimus oral capsule, Accord, 1 mg, 100 count, NDC 16729-0042-01 - discontinued
    • Tacrolimus oral capsule, Accord, 5 mg, 100 count, NDC 16729-0043-01 - discontinued
    • Tacrolimus oral capsule, Bionpharma, 0.5 mg, 100 count, NDC 69452-0153-20
    • Tacrolimus oral capsule, Bionpharma, 1 mg, 100 count, NDC 69452-0154-20
    • Tacrolimus oral capsule, Bionpharma, 5 mg, 100 count, NDC 69452-0155-20
    • Tacrolimus oral capsule, Major, 0.5 mg, unit-dose blister pack, 100 count, NDC 00904-6623-61
    • Tacrolimus oral capsule, Major, 1 mg, unit-dose blister pack, 100 count, NDC 00904-6625-61 - discontinued
    • Tacrolimus oral capsule, Major, 5 mg, unit-dose blister pack, 100 count, NDC 00904-6624-61
    • Tacrolimus oral capsule, Sandoz, 0.5 mg, 100 count, NDC 00781-2102-01
    • Tacrolimus oral capsule, Sandoz, 1 mg, 100 count, NDC 00781-2103-01
    • Tacrolimus oral capsule, Sandoz, 5 mg, 100 count, NDC 00781-2104-01

Reason for the Shortage

    • Accord has tacrolimus on temporary discontinuation due to raw ingredient shortage.
    • Astellas has Prograf available.
    • Bionpharma did not provide a reason for the shortage.
    • Lannett has discontinued tacrolimus capsules.
    • Major did not provide a reason for the shortage.
    • Mylan has tacrolimus available.
    • Sandoz has tacrolimus on allocation.

Available Products

    • Prograf oral capsule, Astellas, 0.5 mg, 100 count, NDC 00469-0607-73
    • Prograf oral capsule, Astellas, 1 mg, 100 count, NDC 00469-0617-73
    • Prograf oral capsule, Astellas, 1 mg, unit-dose 100 count, NDC 00469-0617-11
    • Prograf oral capsule, Astellas, 5 mg, unit-dose 100 count, NDC 00469-0657-11
    • Prograf oral capsule, Astellas, 5 mg, 100 count, NDC 00469-0657-73
    • Tacrolimus oral capsule, Dr. Reddy's, 0.5 mg, 100 count, NDC 55111-0525-01
    • Tacrolimus oral capsule, Dr. Reddy's, 1 mg, 100 count, NDC 55111-0526-01
    • Tacrolimus oral capsule, Dr. Reddy's, 5 mg, 100 count, NDC 55111-0527-01
    • Tacrolimus oral capsule, Mylan, 0.5 mg, 100 count, NDC 00378-2045-01
    • Tacrolimus oral capsule, Mylan, 1 mg, 100 count, NDC 00378-2046-01
    • Tacrolimus oral capsule, Mylan, 5 mg, 100 count, NDC 00378-2047-01
    • Tacrolimus oral capsule, Strides Pharma, 0.5 mg, 100 count, NDC 64380-0720-06
    • Tacrolimus oral capsule, Strides Pharma, 1 mg, 100 count, NDC 64380-0721-06
    • Tacrolimus oral capsule, Strides Pharma, 5 mg, 100 count, NDC 64380-0722-06

Estimated Resupply Dates

    • Accord has temporarily discontinued tacrolimus 0.5 mg, 1 mg, and 5 mg capsules.
    • Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company cannot estimate a release date.
    • Major has tacrolimus 0.5 mg capsules on back order and the company estimates a release date of mid-April 2020. Tacrolimus 5 mg capsules are available in limited quantities.
    • Sandoz has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules in 100 count on allocation.
    • Strides has tacrolimus 1 mg capsules on allocation.

Updated

Updated March 4, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 4, 2019 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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