fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79

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: 10030060 Exp. 11/21/2019, 10030574 Exp. 11/28/2019, 10031353 Exp. 12/12/2019, 10031677 Exp. 12/20/2019, 10031622 Exp. 12/19/2019, 10031419 Exp. 12/15/2019, 10031769 Exp. 12/26/2019, 10031826 Exp. 12/23/2019, 10032287 Exp. 12/30/2019
  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 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79

Product Codes/Lot Numbers:

Lots: 10030060 Exp. 11/21/2019, 10030574 Exp. 11/28/2019, 10031353 Exp. 12/12/2019, 10031677 Exp. 12/20/2019, 10031622 Exp. 12/19/2019, 10031419 Exp. 12/15/2019, 10031769 Exp. 12/26/2019, 10031826 Exp. 12/23/2019, 10032287 Exp. 12/30/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0570-2020

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