FDAClass IIDecember 11, 2019

fentaNYL 100 mcg/2 mL recall: Particulate Matter

fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43

Why was fentaNYL 100 mcg/2 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: 10029772 Exp. 11/17/2019, 10030627 Exp. 11/22/2019, 10030626 Exp. 11/21/2019, 10030408 Exp. 11/25/2019, 10030512 Exp. 11/27/2019, 10030408 Exp. 11/25/2019, 10031107 Exp. 12/5/2019, 10031268 Exp. 12/10/2019, 10031437 Exp. 12/15/2019, 10031821 Exp. 12/23/2019, 10032285 Exp. 12/30/2019

Product
fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
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