Drug 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
D-0370-2024
Product summary
- Event
- Event 94184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,752 bags
- Official record key
drug-enforcement:D-0370-2024
Official wording
Reason: 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.
Code information: Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility