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0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Brau...

FDA Recall #D-0076-2023 — Class II — November 25, 2022

Recall #D-0076-2023 Date: November 25, 2022 Classification: Class II Status: Terminated

Product Description

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Reason for Recall

Lack of sterility assurance: Bags have the potential to leak.

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

756 bags

Distribution

FL, NJ, PA

Code Information

Lot: 0061832446 Exp. 31 Oct 2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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