Recalls / Class I
Class ID-0079-2023
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
- Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
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
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 489,600 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-11-28
- FDA classified
- 2022-12-13
- Posted by FDA
- 2022-12-21
- Terminated
- 2025-10-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0079-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.