Why it was recalled
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
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
Lot numbers, UPCs & expiration codes
Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0555-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 23, 2024
- FDA report date
- Jun 26, 2024
- Quantity
- 70,125 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0555-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94685
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
- Postal code
- 08520-1401
- Report date
- Jun 26, 2024
- Product type
- Drugs
- Recall number
- D-0555-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 70,125 vials
- Reason for recall
- Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2024