fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75

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: 10030341 11/24/2019, 10031102 12/6/2019, 10031555 Exp. 12/18/2019, 10031554 Exp. 12/18/2019, 10031803 Exp. 12/23/2019, 10031776 Exp. 12/22/2019, 10032266 Exp. 12/30/2019, 10032267 Exp. 12/30/2019, 10032321 Exp. 12/31/2019, 10032320 Exp. 12/31/2019, 10032544 Exp. 1/5/2020, 10032515 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 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75

Product Codes/Lot Numbers:

Lots: 10030341 11/24/2019, 10031102 12/6/2019, 10031555 Exp. 12/18/2019, 10031554 Exp. 12/18/2019, 10031803 Exp. 12/23/2019, 10031776 Exp. 12/22/2019, 10032266 Exp. 12/30/2019, 10032267 Exp. 12/30/2019, 10032321 Exp. 12/31/2019, 10032320 Exp. 12/31/2019, 10032544 Exp. 1/5/2020, 10032515 Exp. 1/5/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0571-2020

Related Recalls