FDAClass IIJuly 16, 2014

Heparin Sodium in 5% Dextrose Injection recall: Sterility Concern

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira…

Why was Heparin Sodium in 5% Dextrose Injection recalled?

Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.

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 # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16

Product
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira…
Recalling firm
Hospira Inc.
Quantity
142,152 bags
Distribution
Nationwide
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls