FDA recall D-1035-2014

Hospira Inc. · Class II · drug

Product

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05

Reason for recall

Lack of Assurance of Sterility; potential leakage from administrative port.

Distribution

Nationwide including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-01-09
Report date: 2014-02-05
Termination date: 2015-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1035-2014