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D-1208-2015 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1208-2015 was initiated by Baxter Healthcare Corp. on Mar 24, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) The recall status is terminated (terminated Feb 7, 2017). Affected quantity: 202,824 Bags.

Recall Details

Product Type: Drugs
Report Date: Jul 15, 2015
Initiation Date: Mar 24, 2015
Termination Date: Feb 7, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 202,824 Bags

Product Description

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02

Reason for Recall

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Distribution Pattern

US, Puerto Rico, and Bermuda

Code Information

Lot #: C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1208-2015
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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