Why it was recalled
Lack of Assurance of Sterility
Product description
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Lot numbers, UPCs & expiration codes
Lots: 10006417 and 10006418, Exp. 11/30/2026
Where it was sold
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-0303-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2025
- FDA report date
- Apr 2, 2025
- Quantity
- 103,950 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0303-2025, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 96481
- Address
- 1245 Blowing Rock Blvd
- Code information
- Lots: 10006417 and 10006418, Exp. 11/30/2026
- Postal code
- 28645-3618
- Report date
- Apr 2, 2025
- Product type
- Drugs
- Recall number
- D-0303-2025
- Classification
- Class II
- Recalling firm
- Exela Pharma Sciences LLC
- Product quantity
- 103,950 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 27, 2025