PlainRecalls
FDA Drug Critical Class I Terminated

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

Reported: June 3, 2015 Initiated: March 11, 2015 #D-1108-2015

Product Description

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

Reason for Recall

Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Details

Recalling Firm
Hospira Inc.
Units Affected
24,744 flexible container bags
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.. Recalled by Hospira Inc.. Units affected: 24,744 flexible container bags.
Why was this product recalled?
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Which agency issued this recall?
This recall was issued by the FDA Drug on June 3, 2015. Severity: Critical. Recall number: D-1108-2015.