Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Product description
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Lot numbers, UPCs & expiration codes
Lot # 10004077, Exp. 02/28/2026
Where it was sold
Nationwide in the USA
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-0620-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0620-2025, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 97348
- Address
- 1245 Blowing Rock Blvd
- Code information
- Lot # 10004077, Exp. 02/28/2026
- Postal code
- 28645-3618
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0620-2025
- Classification
- Class II
- Recalling firm
- Exela Pharma Sciences LLC
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 30, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 5, 2025