LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
FDA recall notice · announced June 3, 2015 · Hospira
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
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
Notes
Distribution: Nationwide
Lot/code information: Lot # 40-008-JT; Exp. 04/01/16
Quantity: 24,744 flexible container bags
Status: Terminated
Products in this recall event:
- LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08. (D-1108-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.