FDAClass IIAugust 27, 2014

fentaNYL 200 mcg/100 mL recall: Sterility Concern

fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office…

Why was fentaNYL 200 mcg/100 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?

Lot 7250-0 Exp. 08/14

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office…
Recalling firm
Healix Infusion Therapy, Inc.
Quantity
12 bags
Distribution
Texas and Georgia
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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