FDAFDA · Food and drugs·Recall number D-0555-2024
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
Published June 26, 2024 · Recall initiated: May 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- Eugia US LLC
- Distributor
- USA Nationwide
- UPC
- 0355150239306
- Lot
- Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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