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
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
Failed Impurities/Degradation Specifications