FDA recall D-0555-2024

Eugia US LLC · Class II · 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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-05-23
Report date: 2024-06-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0555-2024