fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Ch...
FDA Recall #D-0562-2020 — Class II — November 12, 2019
Product Description
fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recalling Firm
QuVa Pharma, Inc. — Sugar Land, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
Nationwide.
Code Information
Lots: 10029343 Exp. 11/15/2019, 10029344 Exp. 11/15/2019, 10029345 Exp. 11/15/2019, 10029895 Exp. 11/20/2019, 10029918 Exp. 11/20/2019, 10029919 Exp. 11/20/2019, 10029895 Exp. 11/20/2019, 10030398 Exp. 11/25/2019, 10030399 Exp. 11/25/2019, 10030400 Exp. 11/25/2019, 10031089 Exp. 12/6/2019, 10031059 Exp. 12/5/2019, 10031060 Exp. 12/5/2019, 10031061 Exp. 12/5/2019, 10031326 Exp. 12/12/2019, 10031327 Exp. 12/12/2019, 10031507 Exp. 12/17/2019, 10031480 Exp. 12/19/2019, 10031618 Exp. 12/19/2019, 10031619 Exp. 12/19/2019, 10031672 Exp. 12/20/2019, 10031618 Exp. 12/19/2019, 10031504 Exp. 12/18/2019, 10031733 Exp. 12/22/2019, 10031734 Exp. 12/22/2019, 10031672 Exp. 12/20/2019, 10031815 Exp. 12/23/2019, 10031505 Exp. 12/18/2019, 10031506 Exp. 12/17/2019, 10031328 Exp. 12/12/2019, 10031816 Exp. 12/23/2019, 10031897 Exp. 12/25/2019, 10031919 Exp. 12/25/2019, 10031847 Exp. 12/24/2019, 10031791 Exp. 12/23/2019, 10031792 Exp. 12/23/2019, 10031793 Exp. 12/23/2019, 10031817 Exp. 12/23/2019, 10032279 Exp. 12/31/2019, 10031847 Exp. 12/24/2019, 10032279 Exp. 12/31/2019, 10032334 Exp. 12/31/2019, 10032368 Exp. 1/1/2020, 10032392 Exp. 1/1/2020, 10032278 Exp. 12/31/2019, 10032251 Exp. 12/30/2019, 10032252 Exp. 12/30/2019, 10032930 Exp. 1/13/2020, 10032850 Exp. 1/12/2020, 10032584 Exp. 1/6/2020, 10032850 Exp. 1/12/2020, 10032900 Exp. 1/13/2020, 10032583 Exp. 1/7/2020, 10032901 Exp. 1/13/2020, 10032931 Exp. 1/16/2020, 10032900 Exp. 1/13/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.