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.
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