FDA recall D-0958-2016

Baxter Healthcare Corp. · Class I · drug

Product

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06

Reason for recall

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-12-15
Report date: 2016-06-15
Termination date: 2022-04-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0958-2016