PlainRecalls
FDA Drug Critical Class I Terminated

Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

Reported: January 22, 2014 Initiated: August 30, 2013 #D-461-2014

Product Description

Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.

Details

Recalling Firm
Hospira Inc.
Units Affected
17,256 containers
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.. Recalled by Hospira Inc.. Units affected: 17,256 containers.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Critical. Recall number: D-461-2014.