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U.S. Department of Health and Human Services

FDA Drug Shortages

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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

American Regent/Luitpold (Reverified 12/11/2014)

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

Fresenius Kabi USA, LLC (Revised 12/17/2014)

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 December 2014. Check wholesalers for inventory on all presentations. Demand increase for the drug
20 mg/5 mL single dose vial (NDC 63323-0165-05) Backordered. Next release anticipated December 2014. 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 (Revised 12/09/2014)

Company Contact Information:
888-258-4199

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) Unavailable. Estimated Recovery: TBD Demand increase for the drug
4mg/mL Pkg of 25 (NDC 67457-423-12) Unavailable Estimated Recovery: TBD Demand increase for the drug
100mg/10mL (10mg/mL) Pkg of 10 (NDC 67457-420-10) Available Demand increase for the drug

West-Ward Pharmaceuticals (Revised 12/02/2014)

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 and available in the December 2014 timeframe. Product will be made available as it is released. Increase in prooduct demand due to market supply issues.
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