FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dexamethasone Sodium Phosphate Injection
Status: Currently in Shortage
»Date first posted: 02/08/2019
»Therapeutic Categories: Dermatology; Endocrinology/Metabolism; Gastroenterology; Hematology; Neurology; Oncology; Ophthalmology; Other; Pulmonary/Allergy; Rheumatology

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Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 05/02/2022)

Company Contact Information:
866-850-2876

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/1 mL SDV (NDC 55150-237-01) On long term backorder On long term backorder Delay in shipping of the drug
20 mg/5 mL MDV (NDC 55150-238-05) On long term backorder On long term backorder Delay in shipping of the drug
120 mg/30 mL MDV (NDC 55150-239-30) Currently on backorder - next shipment anticipated Mid June Sporadic availability expected. Demand increase for the drug
10 mg/1 mL SDV (NDC 55150-304-25) Currently on backorder, next shipment Mid June Check wholesalers for inventory Demand increase for the drug
100 mg/10 mL MDV (contains preservative)(NDC 55150-305-10) Available Sporadic availability expected. Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 05/04/2022)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg per 1 mL, Single dose Simplist syringe, preservative free (NDC 76045-106-10) Available Check wholesalers for inventory. Increase in demand
10 mg per 1 mL, Single dose Simplist syringe, preservative free (NDC 76045-109-10) 2 month expiry (7/2022 expiry) dating available by request. Check wholesalers for inventory. Increase in demand
20 mg per 5 mL (4 mg per mL); MDV; Amber vial (NDC 63323-165-05) Available Check wholesalers for inventory. Increase in demand
100 mg per 10 mL (10 mg per mL); MDV; Amber Vial (NDC 63323-516-10) Available Check wholesalers for inventory. Increase in demand
120 mg per 30 mL (4 mg per mL); MDV; Amber Vial (NDC 63323-165-30) Available Check wholesalers for inventory. Increase in demand
4 mg per mL (4 mg per mL); SDV; Amber Vial (NDC 63323-165-01) Available Check wholesalers for inventory. Increase in demand
10 mg per mL (10 mg per mL); SDV; Preservative Free; Amber Vial (NDC 63323-506-01) Available Check wholesalers for inventory. Increase in demand

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 04/08/2022)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/mL, 1 mL vial (NDC 0641-6145-25) This presentation is temporarily on backorder. Additional lots are scheduled for manufacturing and will be available in the April 2022 timeframe. Product will be made available as it is released. Other
4 mg/mL, 5 mL vial (NDC 0641-6146-25) This presentation is temporarily on backorder. Additional lots are scheduled for manufacturing and will be available in the April - May 2022 timeframe. Product will be made available as it is released. Other
10 mg/mL, 1 mL vial (NDC 0641-0367-25) Inventory is currently available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Other

Mylan Institutional, a Viatris company (Reverified 05/04/2022)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexamethasone Sodium Phosphate Injection SDV [4 mg / 1 ml] 25PK (NDC 67457-423-12) Available Demand increase for the drug
Dexamethasone Sodium Phosphate Injection MDV [20 mg / 5 ml] 25PK (NDC 67457-422-54) Available Demand increase for the drug
Dexamethasone Sodium Phosphate Injection MDV [120 mg / 30 ml] 25 PK (NDC 67457-421-30) Available Demand increase for the drug
Dexamethasone Sodium Phosphate Injection MDV [100 mg / 10 ml] 10PK (NDC 67457-420-10) Available Demand increase for the drug

Somerset Therapeutics, LLC (Reverified 04/20/2022)

Company Contact Information:
732-554-1019

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL, 1 mL Single Dose Vial (Preservative Free)(NDC 70069-021-25) Available

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