0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

FDA recall notice · announced April 29, 2015 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

Reason for recall

Lack of Sterility Assurance: The product has the potential to leak at the administrative port.

Notes

Distribution: Nationwide
Lot/code information: Lot# 44-110-JT; Exp 08/16
Quantity: 128,050 ADD-Vantage flexible containers
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67 (D-0490-2015)

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