Class II
Ongoing
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
This recall is currently active, issued June 26, 2024. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- May 23, 2024
- Posted
- June 26, 2024
- Recall Number
- D-0555-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 70,125 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Distribution
USA Nationwide
Lot / Code Info
Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
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