FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure
Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates possible serious adverse health consequences. Although no illnesses or injuries have been reported, the manufacturing defect involving elevated chemical impurities in an injectable medication constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Dexamethasone Sodium Phosphate injection USP (120mg per 30mL) has been recalled due to failed impurity specifications. Quality testing identified that sulfonic acid adduct of dexamethasone phosphate levels exceeded specification limits in affected batches.
The recall involves 70,125 vials distributed nationwide by AuroMedics Pharma LLC. Affected lot numbers are 3DS23001, 3DS23004, 3DS23009, and 3DS23011. The product was manufactured by Eugia US LLC with NDC 55150-239-30.
This is a Class II FDA recall. Healthcare providers and patients who have received this medication should contact their healthcare provider or pharmacist for guidance regarding any vials that may have been dispensed or administered.
The recalled product
- Product
- DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable Corticosteroid
- Hazard
- chemical-impurity
- degradation-product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: 3DS23001
- 3DS23004
- Exp 6/30/2024
- 3DS23009
- 3DS23011
- Exp 7/31/2024
UPCs (2)
- 0355150239306
- 0355150237012
Distribution
Distributed nationwide across the United States.
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