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 04/22/2021)

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) 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.) (Reverified 04/23/2021)

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) Available Check wholesalers for inventory Demand increase for the drug

Baxter Healthcare (Reverified 04/28/2021)

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 (Reverified 04/30/2021)

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) Available 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) Available 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) 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

Gland Pharma Limited (New 03/30/2021)

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 04/08/2021)

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) This presentation is temporarily on backorder. Additional lots will be available in the April 2021 timeframe. Product will be made available as it is released. Demand increase for the drug

HQ Specialty Pharma (Reverified 04/29/2021)

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 04/20/2021)

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 (Revised 04/27/2021)

Company Contact Information:
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
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) Intermittent supply available Demand increase for the drug

Par Pharmaceutical (Reverified 05/04/2021)

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 05/07/2021)

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: May 2021; Estimated Recovery: September 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 04/28/2021)

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) Currently on backorder, Next shipment expected by 2nd week of May 2021 Demand increase for the drug

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