FDA Drug recall D-0267-2025
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,…
- FDA Drug
- Class I
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class I recall of 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,… by Icu Medical, citing 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 strengt….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0267-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| ndc | 0990-7074-26 |
|---|---|
| ndc | 0990-7075-14 |
| ndc | 0990-7075-26 |
| ndc | 0990-7077-14 |
| ndc | 0990-7077-26 |
| ndc | 0030990707 |
| ndc | 3030990707 |
| code_info | Lot 1023172, Exp Date: 31 January 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0267-2025%22
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