FDAHealthMarch 7, 2025
Exela Pharma Sciences LLC — 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 S
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 7, 2025
Nationwide
What's affected?
- 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
- SODIUM BICARBONATE
- Lot code
- 10006417
Additional details
Lots: 10006417 and 10006418, Exp. 11/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 103,950 vials.
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