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Recall Observatory FDA recall evidence

Drug 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

D-0555-2024

May 23, 2024

Class II

Product summary

Firm
Eugia US LLC
Event
Event 94685
Status
Ongoing
Classification
Class II
Quantity
70,125 vials
Official record key
drug-enforcement:D-0555-2024

Official wording

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

Code information: Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications