PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 5, 2014 Initiated: January 9, 2014 #D-1035-2014

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
15258 bags
Distribution
Nationwide including Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 15258 bags.
Why was this product recalled?
Lack of Assurance of Sterility; potential leakage from administrative port.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 5, 2014. Severity: Moderate. Recall number: D-1035-2014.