Eugia US LLC recalls Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by
Recalled June 26, 2024 · FDA recall D-0555-2024 · Eugia US
Hazard
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. · FDA Class II
Units
70,125 vials
Sold at
USA Nationwide
Description
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →