FDAClass IIJuly 25, 2018

Heparin 25 recall: Sterility Concern

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty…

Why was Heparin 25 recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

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 # 138-20181505@92, BUD 8/23/2018; 138-20181605@78, BUD 8/24/2018

Product
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
240 bags
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls