Potassium Chloride for Injection Concentrate USP — Class II drug recall D-0370-2024
Terminated recall by B. Braun Medical Inc, reported 2024-03-20, distributed nationwide. Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically with
| Recall number | D-0370-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2024-03-06 |
| Classified | 2024-03-08 |
| Reported by FDA | 2024-03-20 |
| Terminated | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 22,752 bags |
| Reason classes | labeling, sterility, packaging |
| NDC | 00264-1944, 00264-1944-20 |
| Lot numbers | J2S007, J3A115 |
| Expiration dates | 2024-12-31, 2025-01-31 |
Product
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reason for recall
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0370-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.