Reported Dec 11, 2019 · Terminated

fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL…

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 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
Lot codes and dates
  • Lots
    • 10029306 Exp. 11/14/2019
    • 10029881 Exp. 11/18/2019
    • 10029748 Exp. 11/17/2019
    • 10029881 Exp. 11/18/2019
    • 10029882 Exp. 11/18/2019
    • 10029854 Exp. 11/19/2019
    • 10029882 Exp. 11/18/2019
    • 10030947 Exp. 12/3/2019
    • 10030894 Exp. 12/2/2019
    • 10030442 Exp. 11/26/2019
    • 10031295 Exp. 12/11/2019
    • 10031319 Exp. 12/11/2019
    • 10031518 Exp. 12/17/2019
    • 10031553 Exp. 12/17/2019
    • 10031468 Exp. 12/16/2019
    • 10032703 Exp. 1/8/2020
    • 10032594 Exp. 1/6/2020
    • 10032543 Exp. 1/5/2020
    • 10031906 Exp. 12/25/2019
    • 10031882 Exp. 12/24/2019
    • 10031802 Exp. 12/23/2019
    • 10032594 Exp. 1/6/2020
    • 10032543 Exp. 1/5/2020
    • 10031906 Exp. 12/25/2019
    • 10031802 Exp. 12/23/2019
    • 10031775 Exp. 12/22/2019
    • 10031582 Exp. 12/18/2019
    • 10032673 Exp. 1/8/2020
    • 10032021 Exp. 12/27/2019
    • 10031582 Exp. 12/18/2019
    • 10032021 Exp. 12/27/2019
    • 10031960 Exp. 12/26/2019
    • 10031906 Exp. 12/25/2019
    • 10031582 Exp. 12/18/2019
    • 10032405 Exp. 1/1/2020
    • 10032021 Exp. 12/27/2019
    • 10031960 Exp. 12/26/2019
    • 10032380 Exp. 1/1/2020
    • 10032673 Exp. 1/8/2020

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, 6:35 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.