Potassium Chloride Injection Recalled Nationwide for Mislabeled Strength
Potassium chloride injectable medication is being recalled due to overwrap labels incorrectly stating strength as 10 mEq instead of 20 mEq. This error could result in incorrect dosing by healthcare providers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I drug recall, which mandates a minimum severity of 4. Although no illnesses or deaths have been reported, the mislabeling of strength on a high-risk injectable potassium chloride medication used in critical care could directly result in serious adverse health consequences from incorrect dosing.
Plain-English summary
Otsuka ICU Medical LLC is recalling Potassium Chloride Injection in 100 mL Flexible Containers used in critical care settings. The affected lot is #1030613 with an expiration date of September 30, 2026, and was distributed nationwide.
The overwrap label on the recalled product incorrectly identifies the strength as Potassium Chloride Injection 10 mEq when it should identify the strength as Potassium Chloride Injection 20 mEq. This labeling error could lead healthcare providers to make incorrect clinical decisions regarding dosing and administration of this critical electrolyte medication.
Healthcare facilities that have received product from lot #1030613 should identify and isolate those units. Providers should be aware of the label discrepancy and verify the actual product specifications through alternative sources before administering this medication.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Category
- Drug — Intravenous Medication
- Hazard
- mis-labeling
- dosage-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1030613
- Exp Date: 09/30/2026
Distribution
Distributed nationwide across the United States.
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