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D-0429-2015 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA drug recall D-0429-2015 was initiated by Baxter Healthcare Corp on Mar 23, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; increased complaints received for leaks The recall status is terminated (terminated Oct 20, 2016). Affected quantity: 196,128 containers.

Recall Details

Product Type: Drugs
Report Date: Apr 8, 2015
Initiation Date: Mar 23, 2015
Termination Date: Oct 20, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 196,128 containers

Product Description

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

Reason for Recall

Lack of Assurance of Sterility; increased complaints received for leaks

Distribution Pattern

Nationwide and Singapore

Code Information

Product code: 2B1308; Lot#: P316497, exp date: 10/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0429-2015
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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