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.

FDA recall notice · announced January 22, 2014 · Hospira

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot# 26-138-JT; Exp. 08/14
Quantity: 17,256 containers
Status: Terminated
Products in this recall event:
- 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. (D-461-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.