Recalls / Class II
Class IID-0555-2024
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
- Brand name
- Dexamethasone Sodium Phosphate
- Generic name
- Dexamethasone Sodium Phosphate
- Active ingredient
- Dexamethasone Sodium Phosphate
- Route
- Intra-articular, Intralesional, Intramuscular, Intravenous, Soft Tissue
- NDCs
- 55150-237, 55150-238, 55150-239
- FDA application
- ANDA206781
- Affected lot / code info
- Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
Why it was recalled
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 70,125 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-05-23
- FDA classified
- 2024-06-14
- Posted by FDA
- 2024-06-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0555-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.