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
FDA recall notice · announced June 26, 2024 · Eugia Us
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: USA Nationwide
Lot/code information: Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
Quantity: 70,125 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0555-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.