Otsuka ICU Medical Recalls One Lot of 0.9% Sodium Chloride Injection After Potassium Chloride Mix-Up
核心洞察
Otsuka ICU Medical LLC (搜索) issued a voluntary nationwide, user-level recall of one lot of 0.9% Sodium Chloride Injection, USP (搜索), 100 mL single pack after a product mix-up.
A customer complaint reported a 10 mEq highly concentrated potassium chloride bag inside an overwrap labeled as 0.9% sodium chloride injection.
The company states inadvertent injection of highly concentrated potassium chloride carries a reasonable probability of adverse events and potentially fatal outcomes.
Otsuka ICU Medical LLC (搜索) is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP (搜索), 100 mL single pack to the user level across the United States after a potential product mix-up, the company announced on Sept. 17, 2026.
The affected lot, 0.9% Sodium Chloride Injection, USP (搜索) (NDC: 0990-7984-23, Lot 1042188), may contain an overwrap labeled as 0.9% Sodium Chloride Injection, USP while the actual product inside is Potassium Chloride Inj. 10 mEq (NDC 0990-7074-26, Lot 1035181). The issue was identified through a customer complaint in which a 10 mEq highly concentrated potassium chloride injection 100 mL bag was found inside an overwrap of 0.9% sodium chloride injection, USP 100 mL.
Risk of Concentrated Potassium Chloride
In its risk statement, the company said there is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. Populations identified as most at risk include premature infants, patients on chronic parenteral nutrition, patients with a history of cardiac arrhythmias (搜索), patients with chronic renal insufficiency (搜索), patients with acute renal failure (搜索), and patients on potassium-sparing diuretics.
For these groups, the company cited a reasonable probability of adverse events including neuromuscular dysfunction such as muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest (搜索). To date, Otsuka ICU Medical LLC (搜索) has not received any reports of adverse events related to this recall.
Affected Lot Details
The recalled lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. The product is supplied as 100 mL in a flexible container, list number 07984-23, with an expiration date of 31 October 2027 and barcode number GTIN (01)30309907984231.
The company noted that the incorrect product overwrapped with a sodium chloride overwrap contains its own label and clearly indicates it to be Potassium Chloride Inj. 10 mEq.
Instructions for Customers
Otsuka ICU Medical LLC (搜索) is notifying customers, including distributors, by letter and requesting the return of all recalled products. Customers and distributors should check inventory locations within their institution for the affected lot, quarantine it, and discontinue use. Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return.
The U.S. Food and Drug Administration (搜索) has been notified of the action. Adverse reactions or quality problems experienced with the product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Consumers can reach ICU Medical at 1-844-654-7780.