🔍 RecallPedia

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37

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: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019, 10029758 Exp. 11/17/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10029897 Exp. 11/20/2019, 10029793 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10030394 Exp. 11/25/2019, 10030395 Exp. 11/25/2019, 10030479 Exp. 11/27/2019, 10030480 Exp. 11/27/2019, 10030481 Exp. 11/27/2019, 10030449 Exp. 11/26/2019, 10030450 Exp. 11/26/2019, 10030451 Exp. 11/26/2019, 10030883 Exp. 12/2/2019, 10030885 Exp. 12/2/2019, 10030507 Exp. 11/27/2019, 10030508 Exp. 11/27/2019, 10030936 Exp. 12/3/2019, 10030937 Exp. 12/3/2019, 10030956 Exp. 12/3/2019, 10030903 Exp. 11/30/2019, 10030904 Exp. 11/30/2019, 10030988 Exp. 12/4/2019, 10030938 Exp. 12/3/2019, 10030955 Exp. 12/3/2019, 10030884 Exp. 11/30/2019, 10030902 Exp. 11/30/2019, 10030986 Exp. 12/4/2019, 10030987 Exp. 12/4/2019, 10031009 Exp. 12/4/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031150 Exp. 12/8/2019, 10031009 Exp. 12/4/2019, 10030506 Exp. 11/27/2019, 10030448 Exp. 11/26/2019, 10031176 Exp. 12/9/2019, 10031385 Exp. 12/9/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031149 Exp. 12/8/2019, 10031234 Exp. 12/10/2019, 10031235 Exp. 12/10/2019, 10031259 Exp. 12/10/2019, 10031261 Exp. 12/10/2019, 10031177 Exp. 12/9/2019, 10031384 Exp. 12/9/2019, 10030426 Exp. 11/26/2019, 10030427 Exp. 11/26/2019, 10031260 Exp. 12/10/2019, 10030957 Exp. 12/3/2019, 10031389 Exp. 12/11/2019, 10030957 Exp. 12/3/2019, 10030904 Exp. 11/30/2019, 10031502 Exp. 12/17/2019, 10031474 Exp. 12/16/2019, 10031503 Exp. 12/17/2019, 10031589 Exp. 12/19/2019, 10031611 Exp. 12/19/2019, 10031565 Exp. 12/18/2019, 10031502 Exp. 12/17/2019, 10031563 Exp. 12/17/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031730 Exp. 12/22/2019, 10031588 Exp. 12/19/2019, 10031589 Exp. 12/19/2019, 10031610 Exp. 12/19/2019, 10031564 Exp. 12/18/2019, 10031565 Exp. 12/18/2019, 10031785 Exp. 12/23/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031729 Exp. 12/22/2019, 10031640 Exp. 12/20/2019, 10031564 Exp. 12/18/2019, 10031786 Exp. 12/23/2019, 10031810 Exp. 12/23/2019, 10031893 Exp. 12/25/2019, 10031894 Exp. 12/25/2019, 10032247 Exp. 12/30/2019, 10032218 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031915 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031864 Exp. 12/24/2019, 10032217 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031842 Exp. 12/24/2019, 10032362 Exp. 1/1/2020, 10032363 Exp. 1/1/2020, 10032387 Exp. 1/1/2020, 10032304 Exp. 12/31/2019, 10032388 Exp. 1/1/2020, 10032554 Exp. 1/6/2020, 10032503 Exp. 1/5/2020, 10032504 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032580 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020
  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 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37

Product Codes/Lot Numbers:

Lots: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019, 10029758 Exp. 11/17/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10029897 Exp. 11/20/2019, 10029793 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10030394 Exp. 11/25/2019, 10030395 Exp. 11/25/2019, 10030479 Exp. 11/27/2019, 10030480 Exp. 11/27/2019, 10030481 Exp. 11/27/2019, 10030449 Exp. 11/26/2019, 10030450 Exp. 11/26/2019, 10030451 Exp. 11/26/2019, 10030883 Exp. 12/2/2019, 10030885 Exp. 12/2/2019, 10030507 Exp. 11/27/2019, 10030508 Exp. 11/27/2019, 10030936 Exp. 12/3/2019, 10030937 Exp. 12/3/2019, 10030956 Exp. 12/3/2019, 10030903 Exp. 11/30/2019, 10030904 Exp. 11/30/2019, 10030988 Exp. 12/4/2019, 10030938 Exp. 12/3/2019, 10030955 Exp. 12/3/2019, 10030884 Exp. 11/30/2019, 10030902 Exp. 11/30/2019, 10030986 Exp. 12/4/2019, 10030987 Exp. 12/4/2019, 10031009 Exp. 12/4/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031150 Exp. 12/8/2019, 10031009 Exp. 12/4/2019, 10030506 Exp. 11/27/2019, 10030448 Exp. 11/26/2019, 10031176 Exp. 12/9/2019, 10031385 Exp. 12/9/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031149 Exp. 12/8/2019, 10031234 Exp. 12/10/2019, 10031235 Exp. 12/10/2019, 10031259 Exp. 12/10/2019, 10031261 Exp. 12/10/2019, 10031177 Exp. 12/9/2019, 10031384 Exp. 12/9/2019, 10030426 Exp. 11/26/2019, 10030427 Exp. 11/26/2019, 10031260 Exp. 12/10/2019, 10030957 Exp. 12/3/2019, 10031389 Exp. 12/11/2019, 10030957 Exp. 12/3/2019, 10030904 Exp. 11/30/2019, 10031502 Exp. 12/17/2019, 10031474 Exp. 12/16/2019, 10031503 Exp. 12/17/2019, 10031589 Exp. 12/19/2019, 10031611 Exp. 12/19/2019, 10031565 Exp. 12/18/2019, 10031502 Exp. 12/17/2019, 10031563 Exp. 12/17/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031730 Exp. 12/22/2019, 10031588 Exp. 12/19/2019, 10031589 Exp. 12/19/2019, 10031610 Exp. 12/19/2019, 10031564 Exp. 12/18/2019, 10031565 Exp. 12/18/2019, 10031785 Exp. 12/23/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031729 Exp. 12/22/2019, 10031640 Exp. 12/20/2019, 10031564 Exp. 12/18/2019, 10031786 Exp. 12/23/2019, 10031810 Exp. 12/23/2019, 10031893 Exp. 12/25/2019, 10031894 Exp. 12/25/2019, 10032247 Exp. 12/30/2019, 10032218 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031915 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031864 Exp. 12/24/2019, 10032217 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031842 Exp. 12/24/2019, 10032362 Exp. 1/1/2020, 10032363 Exp. 1/1/2020, 10032387 Exp. 1/1/2020, 10032304 Exp. 12/31/2019, 10032388 Exp. 1/1/2020, 10032554 Exp. 1/6/2020, 10032503 Exp. 1/5/2020, 10032504 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032580 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0553-2020

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