FDA recall D-0830-2016

Hospira Inc. · Class II · drug

Product

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

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-0830-2016