RecallRadar

FDA Drug recall D-0265-2022

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…

On 2021-12-08 the FDA classified a Class II recall of 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… by Pfizer, citing lack of sterility assurance: bag has the potential to leak.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0265-2022
ClassificationClass II
Statusterminated
Initiated2021-11-30
Published2021-12-08
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

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

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

Identifiers

ndc0409-7100-68
ndc0409-7100-66
ndc0409-7100-69
ndc0409-7100-67
ndc0409-7100-04
ndc0409-7100-02
code_infoLot: 4923608 Exp. 1MAY2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.