FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Azithromycin Tablets
Status: Currently in Shortage
»Date first posted: 04/14/2020
»Therapeutic Categories: Anti-Infective

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Alembic Pharmaceuticals (Revised 05/01/2020)

Company Contact Information:
908-393-9604

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg bottles of 30 (NDC 62332-251-30) Available Other
250 mg carton of 3 blister cards (6 tablets per blister card) (NDC 62332-251-06) Launch in June 2020 Other
500 mg bottle of 30 (NDC 62332-252-30) Available Other
500 mg carton of 3 blister cards (3 tablets per blister card) (NDC 62332-252-03) Launch in June 2020 Other

Aurobindo Pharma (New 05/19/2020)

Company Contact Information:
732-839-9400

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250mg 6x3 Blister Pack/ Carton (NDC 65862064163) Additional supply to be available in May 2020
250mg 30 count bottles (NDC 65862064130) Available Demand increase for the drug
250mg 1x6 Blister Pack/ Carton (NDC 65862064169) Back in stock week 3 of May 2020 Demand increase for the drug
500mg 3x3 Blister Pack/ Carton (NDC 65862064290) Back in stock week 2 of June 2020 Demand increase for the drug
500mg 30 count bottles (NDC 65862064230) Back in stock week 1 of June 2020 Demand increase for the drug

Bionpharma Inc. (Reverified 05/19/2020)

Company Contact Information:
888-611-2466

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg bottles of 30 (NDC 69452-171-13) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug
250 mg Carton of 6 (1 Card of 6 Tablets) (NDC 69452-171-04) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug
250 mg Carton of 18 (3 Cards of 6 Tablets) (NDC 69452-171-73) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug
500 mg bottles of 30 (NDC 69452-172-13) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug
500 mg Carton of 3 (1 Card of 3 Tablets) (NDC 69452-172-74) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug
500 mg Carton of 9 (3 Cards of 3 Tablets) (NDC 69452-172-72) Currently unavailable; Expected to become available early June 2020 Shortage due to manufacturing and supply constraints, excess demand in the country where the product is manufactured and logistic issues for shipping the product from the manufacturing location Shortage of an active ingredient, Delay in shipping of the drug, and Demand increase for the drug

CSPC Ouyi Pharmaceutical Co. Ltd. (Reverified 05/18/2020)

Company Contact Information:
609-356-0210

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
600 mg, 30/bottle (NDC 51224-222-30) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
500 mg, 30/bottle (NDC 51224-122-30) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
250 mg, 30/bottle (NDC 51224-022-30) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
500 mg, Cartons of 1 blister card, 3 tablets per blister card (NDC 51224-122-03) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
500 mg, Cartons of 3 blister card, 3 tablets per blister card (NDC 51224-122-09) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
250 mg, Cartons of 1 blister card, 6 tablets per blister card (NDC 51224-022-06) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug
250 mg, Cartons of 3 blister cards, 6 tablets per blister card (NDC 51224-022-18) Limited supply in the second quarter of 2020 Capacity increase anticipated after July 2020; distributed by TAGI Pharma Inc at 1-815-624-7685, or Toll-free 1-855-225-8244 Demand increase for the drug

HEC Pharm USA Inc. (New 04/22/2020)

Company Contact Information:
267-348-3664

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500 mg carton of 1 blister card (3 tablets per blister card) (NDC 0527-2750-17) Available HEC and its distributor Lannett Company, Inc. in conjunction with FDA has initiated a temporary importation of German approved Azithromycin tablets into the U.S. market to address drug shortage. To place an order, please contact Lannett at (215) 333-9000.

Dear Healthcare Professional Letter

Lupin (Revised 05/21/2020)

Company Contact Information:
866-587-4617

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg – Carton of 3 Blister Cards (6 Tablets per Blister Card) (NDC 6818016013) Available
250 mg Bottle of 30’s (NDC 6818016006) Available
500 mg Carton of 3 Blister Cards (3 Tablets per Blister Card) (NDC 6818016113) Available
Azithromycin Tablets, 500 mg Bottle of 30's (NDC 6818016106) Available
Azithromycin Tablets, 600 mg Bottle of 30’s (NDC 6818016206) Available

Pfizer Pharmaceuticals (Revised 05/22/2020)

Company Contact Information:
800-533-4535

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Zithromax 250 mg tablets; Unit Dose package of 50 (NDC 0069-4061-89) Available Demand increase for the drug
Zithromax 500 mg tablets; Unit Dose package of 50 (NDC 0069-3070-86) Next delivery and Estimated recovery: June 2020 Demand increase for the drug
Zithromax 250 mg tablets; bottle of 30 (NDC 0069-3060-30) Next delivery and Estimated recovery: June 2020 Demand increase for the drug
Zithromax 250 mg tablets; boxes of 3 (Z-PAKS of 6) (NDC 0069-3060-75) Next delivery: June 2020 Estimated recovery: July 2020 Demand increase for the drug
Zithromax 500 mg tablets; bottles of 30 (NDC 0069-3070-30) Next delivery and Estimated recovery: June 2020 Demand increase for the drug
Zithromax 500 mg tablets; boxes of 3 (TRI-PAKS of 3 tablets) (NDC 0069-3070-75) Next delivery and Estimated recovery: June 2020 Demand increase for the drug
250 mg tablets; Blister of 3x6 (NDC 59762-2198-3) Limited Supply Available. Next delivery and Estimated recovery: May 2020 Demand increase for the drug
250 mg tablets; Bottle of 30 (NDC 59762-2198-7) Available Demand increase for the drug

Sandoz (Reverified 05/15/2020)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
600 mg 30 count bottle (NDC 0781-5793-31) Available
500 mg 30 count bottle (NDC 0781-8090-31) Available
500 mg 3 count unit dose (NDC 0781-8090-03) Available
250 mg 30 count bottle (NDC 0781-8089-31) Available
250 mg 6 count unit dose (NDC 0781-8089-26) Available

Teva Pharmaceuticals (Revised 05/19/2020)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg 30 count (NDC 50111-787-10) A backorder is anticipated. The estimated duration is unknown at this time. Product allocations being made based on customer Rx Trends. Teva is experiencing a significant increase in demand Demand increase for the drug
250 mg 6 x 1 blister pack (NDC 50111-787-51) Available
500 mg 3 x 1 blister pack (NDC 50111-788-55) A backorder is anticipated. The estimated duration is unknown at this time. Product allocations being made based on customer Rx Trends. Teva is experiencing a significant increase in demand Demand increase for the drug
500 mg 30 count (NDC 50111-788-10) A backorder is anticipated. The estimated duration is unknown at this time. Product allocations being made based on customer Rx Trends. Teva is experiencing a significant increase in demand Demand increase for the drug
600 mg 30 count (NDC 50111-789-10) Available
250 mg 18 3 x 6 blister pack (NDC 50111-787-66) A backorder is anticipated. The estimated duration is unknown at this time. Product allocations being made based on customer Rx Trends. Teva is experiencing a significant increase in demand Demand increase for the drug
500 mg 3 x 3 blister pack (NDC 50111-788-67) Available

Wockhardt (Reverified 04/23/2020)

Company Contact Information:
800-346-6859

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 MG 3X6T (NDC 64679-0961-05) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
250 mg 30T (NDC 64679-961-01) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
250 mg Unit dose package of 100 (NDC 64679-961-02) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
250 mg Cartons of 3 blister cards (6 tablets per blister card) (NDC 64679-961-05) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
250 mg 500-ct bottle (NDC 64679-961-07) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
500 mg 500 mg, 30T (NDC 64679-0964-01) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
500 mg 500 mg, 3X3T (NDC 64679-0964-05) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
500 mg Unit dose package of 100 (NDC 64679-964-02) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
500 mg Cartons of 3 blister cards (3 tablets per blister card) (NDC 64679-964-05) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
500 mg 500-ct bottle (NDC 64679-964-07) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug
600 mg Bottles of 30 (NDC 64679-962-01) Unavailable Requirements related to complying with good manufacturing practices & demand increase for the drug

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