FDA-Drug2024-03-20Class II
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
B. Braun Medical Inc
Hazard
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.
Sold states
Nationwide in the USA
Affected count
22,752 bags
Manufactured in
2525 Mcgaw Ave, N/A, Irvine, CA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0370-2024Don't want to check this manually?
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