FDAClass IIDecember 11, 2019

fentaNYL 1500 mcg/30 mL recall: Particulate Matter

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478…

Why was fentaNYL 1500 mcg/30 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: 10029934 Exp. 11/19/2019, 10029820 Exp. 11/18/2019, 10029872 Exp. 11/19/2019, 10029873 Exp. 11/19/2019, 10030868 Exp. 11/28/2019, 10030567 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10030567 Exp. 11/28/2019, 10030568 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10031210 Exp. 12/9/2019, 10031211 Exp. 12/9/2019, 10031209 Exp. 12/12/2019, 10031439 Exp. 12/15/2019, 10031700 Exp. 12/22/2019, 10031438 Exp. 12/15/2019, 10031766 Exp. 12/26/2019, 10032225 Exp.12/29/2019, 10032260 Exp. 12/30/2019, 10032343 Exp. 12/31/2019,

Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478…
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