🔍 RecallPedia

fentaNYL 1250 mcg/250 mL (5 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 70092-1444-05

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: 10029186 Exp. 11/18/2019, 10029791 Exp. 11/18/2019, 10030403 Exp. 11/25/2019, 10030456 Exp. 11/27/2019, 10030910 Exp. 12/2/2019, 10030403 Exp. 11/25/2019, 10031154 Exp. 12/8/2019, 10031238 Exp. 12/10/2019, 10031182 Exp. 12/9/2019, 10031130 Exp. 12/8/2019, 10031483 Exp. 12/16/2019, 10031482 Exp. 12/16/2019, 10031621 Exp. 12/19/2019, 10031592 Exp. 12/19/2019, 10031921 Exp. 12/25/2019, 10031869 Exp. 12/24/2019, 10032219 Exp. 12/29/2019, 10032393 Exp. 1/1/2020, 10032369 Exp. 1/1/2020, 10032561 Exp. 1/6/2020, 10032586 Exp. 1/6/2020, 10031898 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 1250 mcg/250 mL (5 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 70092-1444-05

Product Codes/Lot Numbers:

Lots: 10029186 Exp. 11/18/2019, 10029791 Exp. 11/18/2019, 10030403 Exp. 11/25/2019, 10030456 Exp. 11/27/2019, 10030910 Exp. 12/2/2019, 10030403 Exp. 11/25/2019, 10031154 Exp. 12/8/2019, 10031238 Exp. 12/10/2019, 10031182 Exp. 12/9/2019, 10031130 Exp. 12/8/2019, 10031483 Exp. 12/16/2019, 10031482 Exp. 12/16/2019, 10031621 Exp. 12/19/2019, 10031592 Exp. 12/19/2019, 10031921 Exp. 12/25/2019, 10031869 Exp. 12/24/2019, 10032219 Exp. 12/29/2019, 10032393 Exp. 1/1/2020, 10032369 Exp. 1/1/2020, 10032561 Exp. 1/6/2020, 10032586 Exp. 1/6/2020, 10031898 Exp. 12/26/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0567-2020

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