Recalls / Class I
Class ID-0023-2023
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
- Affected lot / code info
- Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024
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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 148,920
- 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-0023-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.