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
Reported: June 26, 2024 Initiated: May 23, 2024 #D-0555-2024
Product Description
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.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 70,125 vials
- Distribution
- USA Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 70,125 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2024. Severity: Moderate. Recall number: D-0555-2024.
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