🔍 RecallPedia

fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36

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: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020
  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 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36

Product Codes/Lot Numbers:

Lots: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0563-2020

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