Reported Dec 11, 2019 · Terminated

fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in…

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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Lot codes and dates
  • Lots
    • 10029288 Exp. 11/14/2019
    • 10029762 Exp. 11/14/2019
    • 10029788 Exp. 11/18/2019
    • 10029838 Exp. 11/19/2019
    • 10029948 Exp. 11/21/2019
    • 10029949 Exp. 11/21/2019
    • 10030337 Exp. 11/24/2019
    • 10029838 Exp. 11/19/2019
    • 10030539 Exp. 11/28/2019
    • 10030943 Exp. 12/3/2019
    • 10030964 Exp. 12/3/2019
    • 10030963 Exp. 12/3/2019
    • 10030964 Exp. 12/3/2019
    • 10030888 Exp. 12/2/2019
    • 10030963 Exp. 12/3/2019
    • 10031129 Exp. 12/8/2019
    • 10031284 Exp. 12/11/2019
    • 10031414 Exp. 12/15/2019
    • 10031435 Exp. 12/16/2019
    • 10031735 Exp. 12/22/2019
    • 10032253 Exp. 12/30/2019
    • 10030455 Exp. 11/26/2019
    • 10032535 Exp. 1/6/2020
    • 10032280 Exp. 12/31/2019
    • 10030455 Exp. 11/26/2019
    • 10032535 Exp. 1/6/2020
    • 10033009 Exp. 1/15/2020
    • 10032585 Exp. 1/14/2020
    • 10033009 Exp. 1/15/2020

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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 7:57 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.