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.) (Reverified 09/25/2020)

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) Available Check wholesalers for inventory Demand increase for the drug

Baxter Healthcare (Reverified 07/23/2020)

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 (Reverified 09/15/2020)

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 08/20/2020)

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) Available Demand increase for the drug

HQ Specialty Pharma (Revised 09/09/2020)

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) Available 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) On backorder. Additional supply estimated in November. 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. (Reverified 09/28/2020)

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 09/29/2020)

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) Available 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 09/24/2020)

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) Next Delivery: September 2020; Estimated Recovery: February 2021 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) Available 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 08/24/2020)

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) Currently in backorder, estimated to continue until Nov 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) Available, Currently shipping and on allocation Demand increase for the drug

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