September 2014 FDA Recall Potassium Chloride by Baxter Healthcare Corp
D-1606-2014 - Correct Labeled Product Mispack

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp on September 8, 2014 for the product Potassium Chloride. The FDA reported the reason for recall as correct labeled product mispack. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1606-2014

Reason for Recall
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Initiated
09-08-2014
Reported
10-01-2014
Quantity
148632 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69130
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-27-2016
Product Description About Product Description
Full technical description of the product.
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

Batch or Lot Expiration Information

Lot# Lot P318220, EXP 05/31/15

Affected Packages Involved in this Recall

0338-0703-41 Potassium Chloride
0338-0703-48 Potassium Chloride
0338-0705-41 Potassium Chloride
0338-0705-48 Potassium Chloride
0338-0709-48 Potassium Chloride