RecallReported September 30, 2026
Recall by Otsuka ICU Medical LLC
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
FDA's enforcement report of September 30, 2026 lists a recall FDA has not yet classified by Otsuka ICU Medical LLC of Austin, TX. Product: 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23. Status: Ongoing.
On the record
- Recalling firm
- Otsuka ICU Medical LLC
- Location
- Austin, TX
- Classification
- Not yet classified by FDA
- Status
- Ongoing
- Product type
- Drugs
- Brand names
- SODIUM CHLORIDE
- Generic names
- SODIUM CHLORIDE
- Recall initiated
- 2026-09-11
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
More
Watch Otsuka ICU Medical LLC
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Otsuka ICU Medical LLC.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.