Recalls / Class II
Class IID-0369-2022
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
- Affected lot / code info
- Lot #: C0001088/P0001317, Exp. Date 08/2023
Why it was recalled
Lack of Assurance of Sterility
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
- 18,960 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-01-11
- FDA classified
- 2022-01-13
- Posted by FDA
- 2022-01-19
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0369-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.