0.9% Sodium Chloride Injection, USP, 100 mL
Product details
- 0.9% Sodium Chloride Injection, USP, 100 mL
Company announcement
Otsuka ICU Medical LLC has issued a voluntary nationwide recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack.
The recall is due to a potential product mix-up where the overwrap for 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may contain 10 mEq POTASSIUM CHLORIDE Injection (NDC 0990-7074-26 Lot 1035181).
The affected product was manufactured on November 13, 2025, and distributed in the United States between December 30, 2025, and June 22, 2026.
To date, no adverse events related to this recall have been reported.
Risk:
There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. For populations most at risk, which include premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics, there is a reasonable probability of adverse events such as neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall.
Impacted states: Nationwide
Products:
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL (UPC code(s): 0990798423)
Contact
For more information, call (844) 654-7780.
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