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D-1326-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1326-2015 was initiated by Baxter Healthcare Corp. on Jul 2, 2015 and is designated Class II. Reason for recall: Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors. The recall status is terminated (terminated May 26, 2016). Affected quantity: 189,912 containers.

Recall Details

Product Type: Drugs
Report Date: Aug 19, 2015
Initiation Date: Jul 2, 2015
Termination Date: May 26, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 189,912 containers

Product Description

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

Reason for Recall

Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

Distribution Pattern

TX and TN

Code Information

Lot #: C964601, Exp 4/30/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1326-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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