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

FDA recall notice · announced March 20, 2024 · B. Braun Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Quantity: 22,752 bags
Status: Terminated
Products in this recall event:
- 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 (D-0370-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.