FDAClass IIMarch 27, 2019

fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl recall: Sterility Concern

fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston…

Why was fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl recalled?

Lack of Assurance of Sterility

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: 01/03/19 1311 21010P Exp. 5/3/2019

Product
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston…
Recalling firm
Advanced Pharma Inc.
Quantity
360 bags
Distribution
Nationwide
Recall date
March 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls