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: 01/15/2013
»Therapeutic Categories: Dermatology; Gastroenterology; Hematology; Ophthalmology; Pediatric; Pulmonary/Allergy; Renal

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American Regent/Luitpold (Reverified 08/16/2016)

Company Contact Information:
800-645-1706

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/mL, 1 mL single dose vial (NDC 00517-4901-25) Unavailable- no product available for release. No plan to manufacture. American Regent is currently not manufacturing Dexamethasone Sodium Phosphate Injection, USP. Other
4 mg/mL, 5 mL multiple dose vial (NDC 00517-4905-25) Unavailable- no product available for release. No plan to manufacture. American Regent is currently not manufacturing Dexamethasone Sodium Phosphate Injection, USP. Other
4 mg/mL, 30 mL multiple dose vial (NDC 00517-4930-25) Unavailable- no product available for release. No plan to manufacture. American Regent is currently not manufacturing Dexamethasone Sodium Phosphate Injection, USP Other

Aurobindo Pharma (Revised 03/14/2016)

Company Contact Information:
732-839-9400

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg per mL, 1 mL single dose vial (NDC 55150-237-01) package of 25 Aurobindo Pharma Ltd. has recently launched Dexamethasone Sodium Phosphate Injection Available Other
4 mg per mL, 30 mL multiple dose vial (NDC 55150-239-30) package of 25 Aurobindo Pharma Ltd. has recently launched Dexamethasone Sodium Phosphate Injection Available Other
4 mg per mL, 5 mL multiple dose vial (NDC 55150-238-05) package of 25 Aurobindo Pharma Ltd. has recently launched Dexamethasone Sodium Phosphate Injection Available Other

BD Rx (Reverified 01/19/2016)

Company Contact Information:
866-943-8534

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/mL single-use Pre-filled syringe (NDC 76045-106-10) Available Please check with your wholesaler for available inventory. Other

Fresenius Kabi USA, LLC (Reverified 08/29/2016)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/mL, 1 mL single dose vial (NDC 63323-0165-01) Backordered. Next release anticipated August 2016. Check wholesalers for inventory on all presentations. Demand increase for the drug
20 mg/5 mL single dose vial (NDC 63323-0165-05) Available Check wholesalers for inventory on all presentations. Demand increase for the drug
120 mg/30 mL multiple dose vial (NDC 63323-0165-30) Available Check wholesalers for inventory on all presentations. Demand increase for the drug
10 mg/mL, single dose vial (NDC 63323-0506-01) Available Check wholesalers for inventory on all presentations. Demand increase for the drug
100 mg/10 mL multiple-dose vial (NDC 63323-0516-10) Available Check wholesalers for inventory on all presentations Demand increase for the drug

Mylan Institutional (Reverified 08/16/2016)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
120mg/30mL (4mg/mL) Pkg of 25 (NDC 67457-421-30) Available Demand increase for the drug
20mg/5mL (4mg/mL) Pkg of 25 (NDC 67457-422-54) Available Demand increase for the drug
4mg/mL Pkg of 25 (NDC 67457-423-12) Available Demand increase for the drug
100mg/10mL (10mg/mL) Pkg of 10 (NDC 67457-420-10) Available Demand increase for the drug
4 mg/mL Pkg of 25 NOVAPLUS (NDC 67457-419-01) Available Demand increase for the drug

West-Ward Pharmaceuticals (Revised 05/02/2016)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mL vial, 10 mg/mL (NDC 0641-0367-25) West-Ward has inventory available Additional lots are scheduled to be manufactured in the May - June 2016 timeframe. Product will be made available as it is released. Increase in prooduct demand due to market supply issues.

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