Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, ...

FDA Recall #D-0585-2025 — Class II — August 4, 2025

Recall #D-0585-2025 Date: August 4, 2025 Classification: Class II Status: Ongoing

Product Description

Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

Reason for Recall

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Recalling Firm

B BRAUN MEDICAL INC — Allentown, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

74,088 containers

Distribution

Nationwide in the US

Code Information

Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated