Recalls / Class II
Class IID-0620-2025
Product
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)
- Brand name
- Sodium Bicarbonate
- Generic name
- Sodium Bicarbonate
- Active ingredient
- Sodium Bicarbonate
- Route
- Intravenous
- NDCs
- 51754-5001, 51754-5011, 51754-5002, 51754-5012
- FDA application
- ANDA211091
- Affected lot / code info
- Lot # 10004077, Exp. 02/28/2026
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Manufacturer
- Exela Pharma Sciences, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-30
- FDA classified
- 2025-09-05
- Posted by FDA
- 2025-09-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0620-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.