RecallRadar

FDA Drug recall D-0417-2015

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026

On 2015-03-25 the FDA classified a Class II recall of 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026 by Hospira, citing lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0417-2015
ClassificationClass II
Statusterminated
Initiated2015-03-05
Published2015-03-25
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Reason

Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Identifiers

ndc0409-7100-68
ndc0409-7100-66
ndc0409-7100-69
ndc0409-7100-67
ndc0409-7100-04
ndc0409-7100-02
ndc0030404097
ndc3030409710
code_infoLot: 37-042-JT, Exp 1JAN2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0417-2015%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.