FDAClass IIDecember 11, 2019

fentaNYL 200 mcg/100 mL recall: Particulate Matter

fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA…

Why was fentaNYL 200 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: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA…
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