FDAClass ISeptember 2, 2020

Heparin Sodium 5 recall: Contamination

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA…

Why was Heparin Sodium 5 recalled?

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

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 #: 1220019289, Exp 08/21/2020.

Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA…
Recalling firm
SCA Pharmaceuticals
Quantity
366 Containers
Distribution
Nationwide within the U.S.
Recall date
September 2, 2020
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls