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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AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 03/05/2019)

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) Backordered — next shipment mid-June 2019. Shortage per manufacturer: Intermittent availability expected. Other
20 mg/5 mL MDV (NDC 55150-238-05) Backordered — next shipment mid-June 2019. Shortage per manufacturer: Intermittent availability expected. Other
120 mg/30 mL MDV (NDC 55150-239-30) Backordered — next shipment mid-June 2019. Shortage per manufacturer: Intermittent availability expected. Other

Fresenius Kabi USA, LLC (Revised 04/16/2019)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
20 mg per 5 mL (4 mg per mL); MDV; Amber vial (NDC 63323-165-05) Backordered. Next release April 2019. Check wholesalers for inventory. Delay in manufacturing
100 mg per 10 mL (10 mg per mL); MDV; Amber Vial (NDC 63323-516-10) Backordered. Next release May 2019. Check wholesalers for inventory. Delay in manufacturing
120 mg per 30 mL (4 mg per mL); MDV; Amber Vial (NDC 63323-165-30) Backordered. Next release May 2019. Check wholesalers for inventory. Delay in manufacturing
4 mg per mL (4 mg per mL); SDV; Amber Vial (NDC 63323-165-01) Backordered. Next release April 2019. Check wholesalers for inventory. Delay in manufacturing
10 mg per mL (10 mg per mL); SDV; Preservative Free; Amber Vial (NDC 63323-506-01) Backordered. Next release April 2019. Check wholesalers for inventory. Increase in demand

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 04/05/2019)

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 to be manufactured in April 2019 timeframe. Product will be made available as it is released. Demand increase for the drug
4 mg/mL, 5 mL vial (NDC 0641-6146-25) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured in April 2019 timeframe. Product will be made available as it is released. Demand increase for the drug
10 mg/mL, 1 mL vial (NDC 0641-0367-25) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured in April 2019 timeframe. Product will be made available as it is released. Demand increase for the drug

Mylan Institutional (Reverified 04/17/2019)

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) Unavailable. Expected recovery: June 2019 Demand increase for the drug
Dexamethasone Sodium Phosphate Injection MDV [120 mg / 30 ml] 25 PK (NDC 67457-421-30) Unavailable. Expected recovery: June 2019 Demand increase for the drug
Dexamethasone Sodium Phosphate Injection MDV [100 mg / 10 ml] 10PK (NDC 67457-420-10) Unavailable. Expected recovery: June 2019 Demand increase for the drug

Somerset Therapeutics, LLC (New 02/08/2019)

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) Currently in Stock (we have capacity constraint but product available at this time). Estimated Release Dates: Released Product Available

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