Potassium Chloride for Injection Concentrate USP recall
FDA recall D-0370-2024 · initiated Mar 6, 2024
B. Braun Medical Inc recalled Potassium Chloride for Injection Concentrate USP in Mar 2024 — an FDA Class II recall (D-0370-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,752 bags
Details
- 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
- Recalling company
- B Braun Medical
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 6, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Potassium Chloride for Injection Concentrate USP recalled?
- B. Braun Medical Inc recalled Potassium Chloride for Injection Concentrate USP in Mar 2024 — an FDA Class II recall (D-0370-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Potassium Chloride for Injection Concentrate USP recalled?
- Per the FDA enforcement record, the reason for recall D-0370-2024 was: 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.
- Is a recalled Potassium Chloride for Injection Concentrate USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Potassium Chloride for Injection Concentrate USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0370-2024.