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

FDA recall notice · announced January 19, 2022 · Exela Pharma Sciences

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: C0001088/P0001317, Exp. Date 08/2023
Quantity: 18,960 vials
Status: Terminated
Products in this recall event:
- 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 (D-0369-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.