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Recall Observatory FDA recall evidence

Drug product

Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

D-0540-2026

April 28, 2026

Class I

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 98795
Status
Ongoing
Classification
Class I
Quantity
95,412 containers
Official record key
drug-enforcement:D-0540-2026

Official wording

Reason: Presence of Particulate Matter.

Code information: Lot #:J4P756, J4S843, Exp 5/31/2027

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter