PlainRecalls
FDA Drug Moderate Class II Terminated

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Reported: July 22, 2015 Initiated: July 2, 2015 #D-1240-2015

Product Description

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Reason for Recall

Lack of assurance of sterility: Potential channel leaks near the threaded vial port.

Details

Recalling Firm
Hospira Inc.
Units Affected
314600 bags
Distribution
United States
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68. Recalled by Hospira Inc.. Units affected: 314600 bags.
Why was this product recalled?
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 22, 2015. Severity: Moderate. Recall number: D-1240-2015.