0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
Summary
The FDA issued a recall for 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Ill by Otsuka ICU Medical LLC. Reason: Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Inject.
Details
Source
Drug Recall
External ID
7d0f3e8c-9064-42c4-85fe-76dac4ad6b48
Action Date
2026-09-30
Status
Ongoing
Category
drug
Product Description
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
Lot/Code Info: Lot #: 1042188, Exp. Date 10/31/2027
Quantity Affected: 258480 bags
Reason for Recall
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
Distribution
Natinowide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-11
Company
Austin, TX
Context & Analysis
This is a unclassified recall.
This was one of 26 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Otsuka ICU Medical LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "7d0f3e8c-9064-42c4-85fe-76dac4ad6b48" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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