Reported Dec 11, 2019 · Terminated

fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx,…

QuVa Pharma, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: QuVa Pharma, Inc. · 1075 W Park One Dr Ste 100 · Sugar Land, TX · 77478-2576

Is this the product you have?

  • fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Lot codes and dates
  • Lots
    • 10029346 Exp. 11/15/2019
    • 10029347 Exp. 11/15/2019
    • 10029982 Exp. 11/22/2019
    • 10029347 Exp. 11/15/2019
    • 10029982 Exp. 11/22/2019
    • 10030017 Exp. 11/24/2019
    • 10029982 11/22/2019
    • 10030017 Exp. 11/24/2019
    • 10030401 Exp. 11/25/2019
    • 10030017 Exp. 11/24/2019
    • 10031092 Exp. 12/6/2019
    • 10030401 Exp. 11/25/2019
    • 10031092 12/6/2019
    • 10031349 Exp. 12/12/2019
    • 10032011 Exp. 12/27/2019
    • 10032012 Exp. 12/27/2019
    • 10032505 Exp. 1/5/2020
    • 10032447 Exp. 1/2/2020
    • 10032932 Exp. 1/13/2020

This recall covers 27 products

The agency filed one notice per product. You are reading one of them; the other 26 are below.

14 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 5, 2020 · Data as of Sep 19, 7:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.