Recalls / Class I
Class ID-0022-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
- 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 # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024.
Why it was recalled
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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
- 2,123,040 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-10-04
- FDA classified
- 2022-10-27
- Posted by FDA
- 2022-11-02
- Terminated
- 2025-10-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0022-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.