Class IIOngoing

Dexamethasone Sodium Phosphate injection USP recall

FDA recall D-0555-2024 · initiated May 23, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Details

Product: Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30
Recalling company: Eugia Pharma
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: May 23, 2024
FDA report date: Jun 26, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0555-2024 ↗

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