8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: E
Summary
The FDA issued a Class II for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx by Exela Pharma Sciences LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0369-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: C0001088/P0001317, Exp. Date 08/2023
Quantity Affected: 18,960 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-11
Company
Lenoir, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Exela Pharma Sciences LLC has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exela Pharma Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exela Pharma Sciences LLC have FDA actions?
Exela Pharma Sciences LLC has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0369-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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