Potassium Chloride for Injection Concentrate USP recall

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.

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