Data Foundry

Drug recalls 2016

0 — Class II drug recall D-0731-201

Terminated recall by Baxter Healthcare Corp., reported 2016-03-09, distributed nationwide. PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an inse

Recall numberD-0731-201
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corp., Deerfield, IL, United States
Recall initiated2016-02-05
Classified2016-02-26
Reported by FDA2016-03-09
Terminated2016-11-16
DistributedNationwide (US)
Quantity257,364 bottles
Reason classesforeign material, specification failure
NDC00338-0048, 00338-0048-02, 00338-0048-03, 00338-0048-04, 00338-0048-05
Lot numbers11/18, G120162

Product

0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03

Reason for recall

PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0731-201. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.