Multi event Drug Recall Enforcement Report Class I voluntary initiated by ICU Medical, Inc., originally initiated on 02-13-2025 for the product POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 The product was recalled due to labeling: label error on declared strength. overwrap labeled as potassium chloride inj 10 meq may contain flexible containers of potassium chloride inj 20 meq. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0268-2025 | 02-13-2025 | 03-19-2025 | Class I | unknown | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq | Ongoing |
| D-0267-2025 | 02-13-2025 | 03-19-2025 | Class I | 67,488 flexible containers | 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 | 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. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0990-7074 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
| 0990-7075 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
| 0990-7077 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
