A reasonable chance it could cause serious harm or death.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
| Brand name | POTASSIUM CHLORIDE |
| Generic name | POTASSIUM CHLORIDE |
| Active ingredient(s) | POTASSIUM CHLORIDE |
| Distributed by / for | ICU Medical, Inc. |
| NDC | 0990-7075-26 |
| Full product label | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 |
| Recalling firm | ICU Medical, Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 67,488 flexible containers |
| Recall initiated | 2025-02-13 |
| Report date | 2025-03-19 |
| Recall completed | — |
| Recall number | D-0267-2025 |
| Classification | Class I |
| FDA status | Ongoing |
| Origin on file | Lake Forest IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗