FDAClass IIDecember 11, 2019

fentaNYL 200 mcg/100 mL recall: Particulate Matter

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx…

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: 10029200 Exp. 11/18/2019, 10030347 Exp. 11/24/2019, 10031325 Exp. 12/16/2019, 10030939 Exp. 12/3/2019, 10031865 Exp. 12/24/2019, 10031758 Exp. 12/26/2019, 10031757 Exp. 12/26/2019, 10032275 Exp. 12/30/2019

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx…
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