FDAClass IIAugust 27, 2014

fentaNYL 2500 mcg/250 mL recall: Sterility Concern

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale…

Why was fentaNYL 2500 mcg/250 mL recalled?

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

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?

Lots 7230-0, 7269-0 Exp. 08/14

Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale…
Recalling firm
Healix Infusion Therapy, Inc.
Quantity
48 bags
Distribution
Texas and Georgia
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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