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 09/13/2021)

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 (New 04/06/2021)

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

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 09/03/2021)

Company Contact Information:
888-238-7880

Presentation	Availability and Estimated Shortage Duration	Related Information	Shortage Reason (per FDASIA)
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)	Available	Check wholesalers for inventory	Demand increase for the drug
200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 55150-209-02)	Currently on backorder - next shipment anticipated first week of Sept	Sporadic availability expected.	Demand increase for the drug

Baxter Healthcare (Reverified 08/31/2021)

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 08/25/2021)

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)	8 month expiry (4/2022 expiry) dating available by request.	Check wholesalers for 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)	8 month expiry (4/2022 expiry) dating available by request.	Check wholesalers for 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 63323-671-00)	Backordered. Next release date not available at this time.	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)	8 month expiry (4/2022 expiry) dating available by request.	Check wholesalers for inventory	Demand increase for the drug

Gland Pharma Limited (Reverified 08/31/2021)

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	Marketed by Dr. Reddy’s Laboratories Inc. Check wholesalers for inventory.
400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 43598-975-58)	Inventory available	Marketed by Dr. Reddy’s Laboratories Inc. Check wholesalers for inventory..

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 07/06/2021)

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 are scheduled for manufacturing to meet demand. Product will be made available as it is released.	Demand increase for the drug

HQ Specialty Pharma (Reverified 08/31/2021)

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)	Available	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 09/10/2021)

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, a Viatris company (Reverified 09/16/2021)

Company Contact Information:
800-796-9526

Presentation	Availability and Estimated Shortage Duration	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
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

Par Pharmaceutical (Reverified 09/01/2021)

Company Contact Information:
800-828-9393

Presentation	Availability and Estimated Shortage Duration	Related Information	Shortage Reason (per FDASIA)
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
100 mcg/mL, 2 mL single dose vial, box of 25 (NDC 42023-146-25)	Par Product Available – Please Check Wholesalers

Pfizer Pharmaceuticals (Revised 09/09/2021)

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		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)	Limited Supply Available. Next Delivery: Septemeber 2021; Estimated Recovery; November 2021		Demand increase for the drug
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	Demand increase for the drug

Slayback Pharma (Revised 05/20/2021)

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		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		Demand increase for the drug