Recall Radar0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
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
Read the official FDA notice →What to do
Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Otsuka ICU Medical LLC — Austin, TX
- Severity
- Class I — serious
- Reported
- September 30, 2026
- Quantity
- 258480 bags
- Status
- Ongoing
- Source
- FDA
Where it went
Natinowide within the United States
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