Recalls / Class II
Class IID-0303-2025
Product
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
- 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
- Lots: 10006417 and 10006418, Exp. 11/30/2026
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Manufacturer
- Exela Pharma Sciences, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 103,950 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-03-07
- FDA classified
- 2025-03-27
- Posted by FDA
- 2025-04-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0303-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.