FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dexmedetomidine Injection
Status: Currently in Shortage
»Date first posted: 04/10/2020
»Therapeutic Categories: Anesthesia

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Accord Healthcare Inc. (Revised 07/02/2020)

Company Contact Information:
800-843-7477

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-239-93) On allocation. Estimated Availability: late July 2020 Expediting manufacture of the product. Experiencing resource constraints and interruption within the supply chain due to the impact of COVID-19. Prioritization is being given to this product. Demand increase for the drug
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-432-93), Novaplus On allocation. Estimated Availability: late July 2020 Expediting manufacture of the product. Experiencing resource constraints and interruption within the supply chain due to the impact of COVID-19. Prioritization is being given to this product. Demand increase for the drug

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 06/04/2020)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 55150-209-02) Currently shipping product although backorder expected to continue through July 2020. Next shipment expected July 2020. Intermittent availability expected. Check wholesalers for inventory. Demand increase for the drug

Baxter Healthcare (Reverified 06/02/2020)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 24 (NDC 0338-9555-24) Available
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 12 (NDC 0338-9557-12) Available
200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 24 (NDC 43066-555-24), Novaplus Available
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 12 (NDC 43066-557-12), Novaplus Available

Fresenius Kabi USA, LLC (Revised 06/25/2020)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
80 mcg/20 mL (4 mcg/mL) in 0.9% sodium chloride, single dose vial, box of 10 (NDC 63323-671-20) Backordered. Next release not available at this time. Demand increase for the drug
200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 25 (NDC 63323-671-50) Backordered. Next release not available at this time. Demand increase for the drug
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 63323-671-00) Available Check wholesalers for inventory Demand increase for the drug
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 63323-421-02) Available Check wholesalers for inventory Demand increase for the drug

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 05/28/2020)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100 mcg/mL, 2 mL vial (NDC 0143-9532-25) This presentation is temporarily on backorder. Additional lots will be available the middle of May. Product will be made available as it is released. Demand increase for the drug

HQ Specialty Pharma (Reverified 06/25/2020)

Company Contact Information:
201-857-8290

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
400 mcg/4 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-600-04) On backorder. Next release is early July 2020 Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. Demand increase for the drug
1000 mcg/10 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-601-04) Limited supply. Allocating product. Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. Demand increase for the drug
200 mcg/50 mL (4 mcg/mL), single dose bag, box of 24 (NDC 44567-602-24) Available Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. Demand increase for the drug
400 mcg/100 mL (4 mcg/mL), box of 24 (NDC 44567-603-24) Available Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. Demand increase for the drug

Jiangsu Hengrui Medicine Co. Ltd. (Revised 06/22/2020)

Company Contact Information:
Athenex: 855-273-0154

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 70860-605-03) Available Distributed by Athenex. To order, contact Athenex at 855-273-0154. Demand increase for the drug

Mylan Institutional (Reverified 06/25/2020)

Company Contact Information:
800-RXMYLAN (1-800-796-9526)

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 67457-251-02) Intermittent supply Demand increase for the drug

Par Pharmaceutical (Revised 07/07/2020)

Company Contact Information:
800-828-9393

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100 mcg/mL, 2 mL single dose vial, box of 25 (NDC 42023-146-25) Available Please check wholesalers for supply

Pfizer Pharmaceuticals (Revised 07/01/2020)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
80 mcg/20 mL (4 mcg/mL) in 0.9% sodium chloride, single dose vial, box of 10 (NDC 0409-1660-20) Limited Supply Available. Weekly Releases. Next Delivery: July 2020; Estimated Recovery: September 2020 Please check with your wholesaler for available inventory Demand increase for the drug
200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 20 (NDC 0409-1660-50) Limited Supply Available. Next Delivery: August 2020; Estimated Recovery: November 2020 Please check with your wholesaler for available inventory Demand increase for the drug
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 0409-1660-10) Available Demand increase for the drug
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 0409-1638-02) Available

Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages

Demand increase for the drug

Slayback Pharma (Revised 07/08/2020)

Company Contact Information:
844-566-2505

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mcg/mL in 0.9% sodium chloride, 50 mL single dose bottle, box of 20 (NDC 71225-126-05) Current backorder estimated to continue until July 2020. Demand increase for the drug
4 mcg/mL in 0.9% sodium chloride, 100 mL single dose bottle, box of 10 (NDC 71225-126-06) Current backorder estimated to continue until July 2020. Demand increase for the drug

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