February 2013 FDA Recall Sodium Chloride by Baxter Healthcare Corp.
D-623-2013 - Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on February 27, 2013 for the product Sodium Chloride. The FDA reported the reason for recall as labeling wrong barcode; it may display wrong product code reflecting 0.9% sodium chloride injection , usp 100 ml in mini-bag plus container instead of 50 ml.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-623-2013

Reason for Recall
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Initiated
02-27-2013
Reported
07-03-2013
Quantity
317,280 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65061
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2015
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

Batch or Lot Expiration Information

Lot# Lot: P293118; Exp Date: 10/13

Affected Packages Involved in this Recall

0338-0553-11 Sodium Chloride
0338-0553-18 Sodium Chloride