RecallRadar

FDA Drug recall D-0881-2018

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc

On 2018-06-27 the FDA classified a Class II recall of 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc by Icu Medical, citing lack of assurance of sterility: Bags have potential to leak.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0881-2018
ClassificationClass II
Statusterminated
Initiated2018-05-31
Published2018-06-27
Last updated2026-09-13 11:52 UTC
CompanyIcu Medical
DistributionUS

Product

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

Reason

Lack of assurance of sterility: Bags have potential to leak.

Identifiers

code_infoLot #: 85-023-JT, Exp 7/1/2019

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-0881-2018%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.