FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Tacrolimus Capsules
Status: Currently in Shortage
»Date first posted: 05/17/2019
»Therapeutic Categories: Transplant

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Accord Healthcare Inc. (Revised 04/20/2020)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count (NDC 1672904101) Limited supply availability. Product will be allocated until at least July 2020 Limited API availability
1 mg 100 count (NDC 1672904201) Limited supply availability. Product will be allocated until at least July 2020 Limited API availability
5 mg 100 count (NDC 1672904301) Limited supply availability. Product will be allocated until at least July 2020 Limited API availability

Astellas (Revised 05/21/2020)

Company Contact Information:
800-727-7003

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
PROGRAF® (tacrolimus) capsules 0.5 mg 100 count bottle (NDC 0469-0607-73) Available
PROGRAF® (tacrolimus) capsules 5 mg 100 count bottle (NDC 0469-0657-73) Available
PROGRAF® (tacrolimus) capsules 1 mg 100 count bottle (NDC 0469-0617-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 0.5 mg 30 count bottle (NDC 0469-0647-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 1 mg 30 count bottle (NDC 0469-0677-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 5 mg 30 count bottle (NDC 0469-0687-73) Available
PROGRAF® Granules (tacrolimus for oral suspension) 0.2 mg unit dose packets (NDC 0469-1230-50) Available
PROGRAF® Granules (tacrolimus for oral suspension) 1 mg unit dose packets (NDC 0469-1330-50) Available

BPI Labs, LLC (New 06/04/2020)

Company Contact Information:
727-471-0850 ext. 275

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottle (NDC 54288-135-01) Available

Dr. Reddy's Laboratories, Inc. (Revised 04/30/2020)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg (NDC 55111-525-01) Inventory is low Additional stocks are expected to arrive during May and June 2020 Demand increase for the drug
1 mg (NDC 55111-526-01) Limited supply allocated to contracted customers until the start of June 2020 Additional stocks are expected to arrive during May 2020 Demand increase for the drug
5 mg (NDC 55111-527-01) Available. One week of backorder expected at the start of June Additional stocks are expected to arrive during June 2020 Demand increase for the drug

Mylan Pharmaceuticals Inc. (Revised 06/25/2020)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg, 100s (NDC 0378-2045-01) Unavailable, recovery in June 2020
1 mg, 100s (NDC 0378-2046-01) Unavailable, recovery in June 2020
5 mg, 100s (NDC 0378-2047-01) Unavailable, recovery in June 2020

Sandoz (Reverified 06/30/2020)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count bottle (NDC 0781-2102-01) Supply Available; intermittent backorder until Jan 2021 Demand increase for the drug
1 mg 100 count bottle (NDC 0781-2103-04) Supply Available; intermittent backorder until Jan 2021 Demand increase for the drug
5 mg 100 count bottle (NDC 0781-2104-01) Supply Available; intermittent backorder until Jan 2021 Demand increase for the drug

Strides Pharma Inc. (Reverified 06/25/2020)

Company Contact Information:
855-273-0146

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottles (NDC 64338-721-06) Available Product available on allocation. Demand increase for the drug
0.5 mg 100 count bottles (NDC 64380-720-06) Currently, we do not distribute this product strength and NDC. We are evaluating options to potentially re-launch this product strength.
5 mg 100 count bottles (NDC 64380-722-06) Currently, we do not distribute this product strength and NDC. We are evaluating options to potentially re-launch this product strength.

Veloxis Pharmaceuticals, Inc. (Reverified 05/07/2020)

Company Contact Information:
919-591-3085

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Envarsus XR 0.75 mg Extended-Release Tablets 30 count (NDC 68992-3075-3) Available
Envarsus XR 0.75 mg Extended-Release Tablets 100 count (NDC 68992-3075-1) Available
Envarsus XR 1 mg Extended-Release Tablets 30 count (NDC 68992-3010-3) Available
Envarsus XR 1 mg Extended-Release Tablets 100 count (NDC 68992-3010-1) Available
Envarsus XR 4 mg Extended-Release Tablets 30 count (NDC 68992-3040-3) Available
Envarsus XR 4 mg Extended-Release Tablets 100 count (NDC 68992-3040-1) Available

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