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0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Wal...

FDA Recall #D-0827-2018 — Class II — November 13, 2017

Recall #D-0827-2018 Date: November 13, 2017 Classification: Class II Status: Terminated

Product Description

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA

Classification

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

Product Type

Drugs

Product Quantity

25,356 1 liter bags

Distribution

Product was distributed throughout the United States.

Code Information

Lot # 17LU05005; Exp. 09/18 Part Number 060-10109

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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