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. (Reverified 08/01/2019)

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) Product under allocation. Shortage duration from July 2019 to March 2020. Limited API availability
1 mg 100 count (NDC 1672904201) Product under allocation. Shortage duration from July 2019 to March 2020. Limited API availability
5 mg 100 count (NDC 1672904301) Product under allocation. Shortage duration from July 2019 to March 2020. Limited API availability

Astellas (Revised 06/21/2019)

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; product under allocation
PROGRAF® (tacrolimus) capsules 5 mg 100 count bottle (NDC 0469-0657-73) Available; product under allocation
PROGRAF® (tacrolimus) capsules 1 mg 100 count bottle (NDC 0469-0617-73) Available; product under allocation
ASTAGRAF XL® (tacrolimus extended release capsules) 0.5 mg 30 count bottle (NDC 0469-0647-73) Available; product under allocation
ASTAGRAF XL® (tacrolimus extended release capsules) 1 mg 30 count bottle (NDC 0469-0677-73) Available; product under allocation
ASTAGRAF XL® (tacrolimus extended release capsules) 5 mg 30 count bottle (NDC 0469-0687-73) Available; product under allocation
PROGRAF® Granules (tacrolimus for oral suspension) 0.2 mg unit dose packets (NDC 0469-1230-50) Available; product under allocation
PROGRAF® Granules (tacrolimus for oral suspension) 1 mg unit dose packets (NDC 0469-1330-50) Available; product under allocation

Dr. Reddy's Laboratories, Inc. (Reverified 08/02/2019)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg (NDC 55111-525-30) Available Releasing product as it becomes available
0.5 mg (NDC 55111-525-01) Available Releasing product as it becomes available
0.5 mg (NDC 55111-525-05) Available Releasing product as it becomes available
0.5 mg unit dose (NDC 55111-525-78) Available Releasing product as it becomes available
1 mg (NDC 55111-526-30) Available Releasing product as it becomes available
1 mg (NDC 55111-526-01) Available Releasing product as it beceomes available
1 mg (NDC 55111-526-05) Available Releasing product as it becomes available
1 mg unit dose (NDC 55111-526-78) Available Releasing product as it becomes available
5 mg (NDC 55111-527-30) Available Releasing product as it becomes available
5 mg (NDC 55111-527-01) Available Releasing product as it becomes available
5 mg (NDC 55111-527-05) Available Releasing product as it becomes available
5 mg unit dose (NDC 55111-527-78) Available Releasing product as it becomes available

Mylan Pharmaceuticals Inc. (Revised 08/08/2019)

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) Available
1 mg, 100s (NDC 0378-2046-01) Available
5 mg, 100s (NDC 0378-2047-01) Available

Sandoz (Reverified 07/30/2019)

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) Available
1 mg 100 count bottle (NDC 0781-2103-04) Available
5 mg 100 count bottle (NDC 0781-2104-01) Available

Strides Pharma Inc. (New 05/17/2019)

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) Currently out of stock - re-supply the first week of June, 2019 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. (Revised 08/12/2019)

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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