November 2014 FDA Recall Potassium Chloride by Baxter Healthcare Corp.
D-0256-2015 - Labeling
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on November 10, 2014 for the product Potassium Chloride. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0256-2015
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
11-10-2014
12-03-2014
63,360 container bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
11-03-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Batch or Lot Expiration Information
Lot# : P319160, Exp 06/30/15
