PlainRecalls
FDA Drug Moderate Class II Terminated

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Reported: December 8, 2021 Initiated: November 30, 2021 #D-0265-2022

Product Description

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Reason for Recall

Lack of sterility assurance: bag has the potential to leak.

Details

Recalling Firm
Pfizer Inc.
Units Affected
765 bags
Distribution
USA Nationwide
Location
New York, NY

Frequently Asked Questions

What product was recalled?
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66. Recalled by Pfizer Inc.. Units affected: 765 bags.
Why was this product recalled?
Lack of sterility assurance: bag has the potential to leak.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 8, 2021. Severity: Moderate. Recall number: D-0265-2022.