Otsuka Icu Medical Llc: 0.9% Sodium Chloride Injection
Recall Summary ICU Medical is recalling 0.9% Sodium Chloride Injection (100 mL) because some packages may contain potassium chloride instead of the labeled sodium chloride due to a labeling mix-up. The affected product was distributed nationwide in the United States. This recall affects healthcare facilities and providers who received this medication.
- Recalling firm
- Otsuka ICU Medical LLC
- Product
- 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
- 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 Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-11
- Status
- Ongoing
- Distribution
- Natinowide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b1d4d3f5-9c54-421f-b096-ce9149a5add6