0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798
Summary
The FDA issued a Class II for 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Fo by Otsuka ICU Medical LLC. Reason: Lack of Assurance of Sterility: Potential for flexible container leaks..
Details
Source
Drug Recall
External ID
D-0143-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lot/Code Info: Lot # 1029921, Exp Date: 28 February 2027
Quantity Affected: 509,360 100 mL bags
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Distribution
Distributed Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-27
Company
Austin, TX
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 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Otsuka ICU Medical LLC has 3 FDA actions in our database, including 3 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 (Otsuka ICU Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Otsuka ICU Medical LLC have FDA actions?
Otsuka ICU Medical LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0143-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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