FDAClass IIDecember 11, 2019

fentaNYL 1000 mcg/100 mL recall: Particulate Matter

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar…

Why was fentaNYL 1000 mcg/100 mL recalled?

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

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: 10030341 11/24/2019, 10031102 12/6/2019, 10031555 Exp. 12/18/2019, 10031554 Exp. 12/18/2019, 10031803 Exp. 12/23/2019, 10031776 Exp. 12/22/2019, 10032266 Exp. 12/30/2019, 10032267 Exp. 12/30/2019, 10032321 Exp. 12/31/2019, 10032320 Exp. 12/31/2019, 10032544 Exp. 1/5/2020, 10032515 Exp. 1/5/2020

Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar…
Recalling firm
QuVa Pharma, Inc.
Distribution
Nationwide.
Recall date
December 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls