🔍 RecallPedia

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36

Class I - Dangerous
💊 Drugs Recalled: November 12, 2019 QuVa Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031942 Exp. 12/26/2019 10031970 Exp. 12/29/2019 10031971 Exp. 12/29/2019 10031972 Exp. 12/29/2019 10031973 Exp. 12/29/2019 10032273 Exp. 12/30/2019 10032274 Exp. 12/30/2019 10032329 Exp. 12/31/2019 10032330 Exp. 12/31/2019 10032812 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032004 Exp. 12/27/2019 10032028 Exp. 12/27/2019 10032029 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032029 Exp. 12/27/2019 10032030 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10033353 Exp. 1/17/2020 10033352 Exp. 1/16/2020 10031753 Exp. 12/26/2019
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
QuVa Pharma, Inc.
Reason for Recall:
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36

Product Codes/Lot Numbers:

Lots: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031942 Exp. 12/26/2019 10031970 Exp. 12/29/2019 10031971 Exp. 12/29/2019 10031972 Exp. 12/29/2019 10031973 Exp. 12/29/2019 10032273 Exp. 12/30/2019 10032274 Exp. 12/30/2019 10032329 Exp. 12/31/2019 10032330 Exp. 12/31/2019 10032812 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032004 Exp. 12/27/2019 10032028 Exp. 12/27/2019 10032029 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032029 Exp. 12/27/2019 10032030 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10033353 Exp. 1/17/2020 10033352 Exp. 1/16/2020 10031753 Exp. 12/26/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0555-2020

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