Reported Dec 11, 2019 · Terminated

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD,…

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 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
Lot codes and dates
  • Lots
    • 10029361 Exp. 11/15/2019
    • 10029362 Exp. 11/15/2019
    • 10029334 Exp. 11/14/2019
    • 10029855 Exp. 11/19/2019
    • 10029856 Exp. 11/19/2019
    • 10030387 Exp. 11/25/2019
    • 10030388 Exp. 11/25/2019
    • 10031026 Exp. 12/12/2019
    • 10031078 Exp. 12/12/2019
    • 10031469 Exp. 12/16/2019
    • 10031493 Exp. 12/16/2019
    • 10031519 Exp. 12/17/2019
    • 10031804 Exp. 12/23/2019
    • 10031105 Exp. 12/12/2019
    • 10031830 Exp. 12/23/2019
    • 10031884 Exp. 12/24/2019
    • 10032704 Exp. 1/8/2020
    • 10032888 Exp. 1/12/2020
    • 10032889 Exp. 1/12/2020
    • 10032913 Exp. 1/13/2020
    • 10032939 Exp. 1/13/2020
    • 10032940 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, 5:03 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.