Data Foundry

Drug recalls 2018

0 — Class II drug recall D-1190-2018

Terminated recall by Baxter Healthcare Corporation, reported 2018-09-26, distributed nationwide. cGMP Deviation

Recall numberD-1190-2018
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2018-09-06
Classified2018-09-15
Reported by FDA2018-09-26
Terminated2020-10-01
DistributedNationwide (US)
Quantity5,184 bags
Reason classescgmp
NDC00338-0043, 00338-0043-03, 00338-0043-04, 00338-0049, 00338-0049-01, 00338-0049-02, 00338-0049-03, 00338-0049-04, 00338-0049-10, 00338-0049-11, 00338-0049-18, 00338-0049-31, 00338-0049-38, 00338-0049-41, 00338-0049-48
Lot numbersP380063
Expiration dates2019-12

Product

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31

Reason for recall

cGMP Deviation

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-1190-2018. 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.