Voluntary Recall of 0.9% Sodium Chloride Injection Due to Product Mix-Up
Otsuka ICU Medical LLC has issued a voluntary nationwide recall for one lot of 0.9% Sodium Chloride Injection, USP, 100mL single pack down to the user level. The recall was initiated because the affected sodium chloride overwrap may actually contain Potassium Chloride Injection 10 mEq.
The issue stems from a product mix-up discovered via a customer complaint, where a highly concentrated potassium chloride bag was found inside a sodium chloride overwrap. Inadvertent administration of concentrated potassium chloride poses severe risks, including cardiac arrest, arrhythmias, neuromuscular dysfunction, and other potentially fatal outcomes, especially in vulnerable populations such as premature infants and patients with renal impairment.
The company is notifying distributors and customers by letter to check inventory, quarantine affected stock, and discontinue its use. Customers are instructed to complete a response form to coordinate product returns.
Key points
- Affected product: 0.9% Sodium Chloride Injection, USP, 100 mL, lot 1042188, NDC 0990-7984-23.
- Potential defect: Overwrap indicates sodium chloride, but contents may be Potassium Chloride Injection 10 mEq, lot 1035181.
- Inadvertent injection of concentrated potassium chloride can lead to fatal outcomes and serious adverse events.
- High-risk populations include premature infants, patients with renal insufficiency, and those with a history of cardiac arrhythmias.
- Customers are advised to check inventory, quarantine affected stock, and stop use immediately.
What it means for you
Clinicians and pharmacists should carefully inspect intravenous solutions before administration or dispensing to verify that the inner container label matches the outer overwrap. Because this is an international safety alert, healthcare professionals in Pakistan should remain vigilant about imported stock and check with DRAP for any related local availability or safety advisories.
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.