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…
Exela Pharma Sciences LLC · Lack of Assurance of Sterility
- Status
- Ongoing
- City
- Lenoir
- State
- NC
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96481
- Recalling firm
- Exela Pharma Sciences LLC
- Address 1
- 1245 Blowing Rock Blvd
- Address 2
- N/A
- Postal code
- 28645-3618
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
- Recall number
- D-0303-2025
- Product quantity
- 103,950 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20250307
- Center classification date
- 20250327
- Report date
- 20250402
- Code info
- Lots: 10006417 and 10006418, Exp. 11/30/2026
- 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
- Harmonized identifiers (openFDA)
- Application number
- ANDA211091
- Brand name
- SODIUM BICARBONATE
- Generic name
- SODIUM BICARBONATE
- Manufacturer name
- Exela Pharma Sciences, LLC
- Product NDC
- 51754-5001, 51754-5011, 51754-5002, 51754-5012
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- SODIUM BICARBONATE
- RxCUI
- 807284, 1868486, 1923484, 2198792
- SPL ID
- 4da0ba66-756d-4b4d-8018-81ca16578ef1
- SPL set ID
- e9698a4f-1a95-4f28-a945-e8009d1d6dd4
- Package NDC
- 51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5, 51754-5012-4, 51754-5001-1
- Is original packager
- true
- UNII
- 8MDF5V39QO