PlainRecalls
FDA Drug Moderate Class II Terminated

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

Reported: July 3, 2013 Initiated: May 4, 2012 #D-619-2013

Product Description

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

Reason for Recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Details

Recalling Firm
Hospira Inc.
Units Affected
2,933,936 units
Distribution
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045. Recalled by Hospira Inc.. Units affected: 2,933,936 units.
Why was this product recalled?
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 3, 2013. Severity: Moderate. Recall number: D-619-2013.