FDA recall D-0831-2016

Product

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

Reason for recall

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Distribution

US: Nationwide and Singapore

Key facts

Status

Terminated

Initiation date

2016-03-08

Report date

2016-04-27

Termination date

2017-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0831-2016