TOPIC: 0.9% Sodium Chloride Injection, USP by Otsuka ICU Medical: Recall - Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Nephrology, Pediatric
ISSUE: Otsuka ICU Medical is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL single pack due to a potential mix-up. The affected lot of 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be Potassium Chloride Injection 10 mEq, (NDC 0990-7074-26) Lot 1035181. The issue has been identified through a customer complaint where 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 Statement: 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 has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used as 0.9% Sodium Chloride Injection single - dose container for intravenous (I.V.) use.
RECOMMENDATIONS:
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Otsuka ICU Medical is notifying its customers, including distributors, of this recall by letter and is requesting the return of all recalled products.
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All customers, including distributors, should check inventory locations within their institution for the affected product, quarantine, and discontinue use.
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Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return.
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For further inquiries, please contact ICU Medical using the information provided on the recall.
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