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D-1336-2015 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1336-2015 was initiated by Baxter Healthcare Corp. on Jul 17, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. The recall status is terminated (terminated Dec 1, 2016). Affected quantity: 189,120 bags.

Recall Details

Product Type: Drugs
Report Date: Aug 26, 2015
Initiation Date: Jul 17, 2015
Termination Date: Dec 1, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 189,120 bags

Product Description

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.

Reason for Recall

Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

Distribution Pattern

Nationwide

Code Information

Lot#: P319921, Exp 12/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1336-2015
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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