FDA-Drug2021-12-08Class II

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

Pfizer Inc.
Hazard

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

Sold states
USA Nationwide
Affected count
765 bags
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0265-2022

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