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 (Revised 01/24/2023)

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)	Limited supply; Recovery mid-February 2023
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 01/24/2023)

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 on backorder - next shipment early February 2023	Check wholesalers for inventory	Demand increase for the drug
200mcg/50mL, single dose bag (NDC 55150-296-10)	Available	Check wholesalers for inventory	Demand increase for the drug
400mcg/100mL, single dose bag (NDC 55150-297-10)	Currently on backorder - next shipment end of January 2023	Check wholesalers for inventory	Demand increase for the drug

Fresenius Kabi USA, LLC (Reverified 01/26/2023)

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 12/16/2022)

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 12/16/2022)

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 01/31/2023)

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 (Revised 01/20/2023)

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)	Available		Other
200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 20 (NDC 0409-1660-50)	Available		Other
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	Search List of Extended Use Dates to Assist with Drug Shortages	Other

Slayback Pharma (Reverified 12/28/2022)

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