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D-1583-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1583-2014 was initiated by Baxter Healthcare Corp. on Jul 30, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; complaints of mold in the overpouch The recall status is terminated (terminated Jun 8, 2016). Affected quantity: 157,080 containers.

Recall Details

Product Type: Drugs
Report Date: Sep 17, 2014
Initiation Date: Jul 30, 2014
Termination Date: Jun 8, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 157,080 containers

Product Description

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

Reason for Recall

Lack of Assurance of Sterility; complaints of mold in the overpouch

Distribution Pattern

Nationwide

Code Information

Lot #C926642, Product Code: 2B1323N

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1583-2014
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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