fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50

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: 10029773 Exp. 11/17/2019, 10029821 Exp. 11/18/2019, 10030351 Exp. 11/21/2019, 10031014 Exp. 12/2/2019, 10030351 Exp. 11/21/2019, 10030912 Exp. 12/2/2019, 10030569 Exp. 11/28/2019, 10030966 Exp. 12/3/2019, 10031796 Exp. 12/23/2019, 10031509 Exp. 12/17/2019, 10031067 Exp. 12/5/2019, 10031156 Exp. 12/16/2019
  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 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50

Product Codes/Lot Numbers:

Lots: 10029773 Exp. 11/17/2019, 10029821 Exp. 11/18/2019, 10030351 Exp. 11/21/2019, 10031014 Exp. 12/2/2019, 10030351 Exp. 11/21/2019, 10030912 Exp. 12/2/2019, 10030569 Exp. 11/28/2019, 10030966 Exp. 12/3/2019, 10031796 Exp. 12/23/2019, 10031509 Exp. 12/17/2019, 10031067 Exp. 12/5/2019, 10031156 Exp. 12/16/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0558-2020

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