ICU Medical POTASSIUM CHLORIDE Inj. recalled due to Mislabeling, USA

United States

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU Medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. The affected product was distributed across the USA.

ICU Medical has identified a potential for some of the product overwraps in one lot to be mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place.

Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states when oral replacement is not feasible and is packaged in 100 mL bags.

Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmia, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:

- NDC Number: 0990-7074-26
- Barcode Number: (01)00309907074269
- Overwrap Description: POTASSIUM CHLORIDE Inj. 10 mEq
- Primary Bag Description: POTASSIUM CHLORIDE Inj. 20 mEq
- Lot Number: 1023172
- Expiration Date: 31 January 2026
- Configuration: 100 mL Flexible Container

- NDC Number: 0990-7075-26
- Barcode Number: (01)00309907075266
- Overwrap Description: POTASSIUM CHLORIDE Inj. 20 mEq
- Primary Bag Description: POTASSIUM CHLORIDE Inj. 20 mEq
- Lot Number: 1023172
- Expiration Date: 31 January 2026
- Configuration: 100 mL Flexible Container

DESCRIPTION OF CASES BEING RECALLED:

- NDC Number: 0990-7075-26
- Barcode Number: (01)30309907075267
- Lot Number: 1023172
- Expiration Date: 31 January 2026
- Configuration: 1 x 24 – 100 mL

ICU Medical is informing its customers, including distributors, about this recall through an official letter and coordinating the return of all affected products. Healthcare professionals in possession of the recalled product should cease use or distribution, as applicable, and return it to the place of purchase.

Consumers are advised to not consume the products and to return them to where they purchased them.

For any questions regarding this recall, consumers can reach ICU Medical via the phone number or email listed in the table below. If consumers experience any issues related to the use of this product, they should consult their physician or healthcare provider.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: ICU Medical
Brand name: ICU Medical
Product recalled: POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq
Reason of the recall: Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.
FDA Recall date: February 14, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride