FDA-Drug2024-06-26Class II
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
Eugia US LLC
Hazard
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Sold states
USA Nationwide
Affected count
70,125 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0555-2024Don't want to check this manually?
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