Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Potassium Chloride for Injection Concentrate USP Recalled by B. Braun Medical Inc Due to Lack of assurance of sterility: pinholes, within the...

Date: March 6, 2024
Company: B. Braun Medical Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B. Braun Medical Inc directly.

Affected Products

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

Quantity: 22,752 bags

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B. Braun Medical Inc

B. Braun Medical Inc has 25 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report