FDAClass IIDecember 3, 2014

Potassium Chloride in 5% Dextrose and 0.45% Sodium recall: Sterility Concern

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL…

Why was Potassium Chloride in 5% Dextrose and 0.45% Sodium recalled?

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15

Product
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL…
Recalling firm
Hospira Inc.
Quantity
836,460 bags
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Recall date
December 3, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls