Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, ...
FDA Recall #D-263-2013 — Class I — October 5, 2012
Product Description
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Reason for Recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Recalling Firm
Hospira Inc. — Lake Forest, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
136,224 flexible containers
Distribution
Nationwide
Code Information
Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated