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Recall Observatory FDA recall evidence

Drug product

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

D-0496-2026

April 02, 2026

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 98693
Status
Ongoing
Classification
Class II
Quantity
17,124 bags
Official record key
drug-enforcement:D-0496-2026

Official wording

Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Code information: Lot # J5H166, J5H167, Exp Date: 30NOV2026.

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility