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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. (Reverified 04/21/2022)

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

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) Available
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-432-93), Novaplus Available

Amneal Pharmaceutical (Reverified 04/07/2022)

Company Contact Information:
866-525-7270

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 bottle (NDC 70121-1388-8 box of 20; NDC 70121-1388-1 individual) Available
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single-dose bottle (NDC 70121-1389-7 box of 10; NDC 70121-1389-1 individual) Available

Baxter Healthcare (Reverified 11/23/2022)

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

Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 11/15/2022)

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 Demand increase for the drug
200mcg/50mL, single dose bag (NDC 55150-296-10) Currently on backorder - next shipment end November 2022 Demand increase for the drug
400mcg/100mL, single dose bag (NDC 55150-297-10) Available Demand increase for the drug

Fresenius Kabi USA, LLC (Reverified 11/14/2022)

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) Available Check wholesaler inventory 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) 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 63323-671-00) Available Demand increase for the drug
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 63323-421-02) Available Demand increase for the drug

Gland Pharma Limited (Reverified 11/18/2022)

Company Contact Information:
866-733-3952

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 bottle, box of 10 (NDC 43598-976-58) Inventory available
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 43598-975-58) Inventory available

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 10/13/2022)

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) Inventory is currently available Additional lots will be scheduled for manufacturing. Product will be made available as it is released. Demand increase for the drug

HQ Specialty Pharma (Reverified 11/08/2022)

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 Demand increase for the drug
1000 mcg/10 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-601-04) Available Demand increase for the drug
200 mcg/50 mL (4 mcg/mL), single dose bag, box of 24 (NDC 44567-602-24) Available Demand increase for the drug
400 mcg/100 mL (4 mcg/mL), box of 24 (NDC 44567-603-24) Available Demand increase for the drug

Jiangsu Hengrui Medicine Co. Ltd. (Reverified 11/08/2022)

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 Demand increase for the drug

Meitheal Pharmaceuticals, Inc. (Reverified 11/14/2022)

Company Contact Information:
844-824-8426

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 71288-505-03) Available

Mylan Institutional, a Viatris company (Reverified 11/23/2022)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.2 mg / 50 ml (Solution in Single Use Vials/Bottles), 20PK (NDC 67457-924-50) Available Demand increase for the drug
0.4 mg / 100 ml (Solution in Single Use Vials/Bottles), 10PK (NDC 67457-925-10) Available Demand increase for the drug
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 (Reverified 09/21/2022)

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) Par Product Available – Please Check Wholesalers
200 mcg/50 mL (4 mcg/mL), 50 mL single dose vial, box of 25 (NDC 42023-186-20) Par Product Available – Please Check Wholesalers
400 mcg/100 mL (4 mcg/mL), 100 mL single dose vial, box of 10 (NDC 42023-187-10) Par Product Available – Please Check Wholesalers

Pfizer Pharmaceuticals (Reverified 11/10/2022)

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) Depleted. Next Delivery: November 2022; Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
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 and Estimated Recovery: November 2022 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 Other
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 0409-1638-02) Available

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Slayback Pharma (Revised 06/01/2022)

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) Available
4 mcg/mL in 0.9% sodium chloride, 100 mL single dose bottle, box of 10 (NDC 71225-126-06) Available
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