PlainRecalls
FDA Drug Moderate Class II Terminated

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045

Reported: July 3, 2013 Initiated: May 4, 2012 #D-616-2013

Product Description

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), 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
216,396 units
Distribution
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045. Recalled by Hospira Inc.. Units affected: 216,396 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-616-2013.