Status
Ongoing
Drug Enforcement D-0303-2025
Lack of Assurance of Sterility
Classification
Class II
Report Date
April 2, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 103,950 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Exela Pharma Sciences LLC
- Address
-
1245 Blowing Rock Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0303-2025
- Event ID
- 96481
- Recall initiation date
- March 7, 2025
- Center classification date
- March 27, 2025
- Code info
- Lots: 10006417 and 10006418, Exp. 11/30/2026
- More code info
- —