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Recall Observatory FDA recall evidence

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

March 06, 2024

Class II

Product summary

Firm
B. Braun Medical Inc
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

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility