🔍 RecallPedia

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

Class I - Dangerous
💊 Drugs Recalled: April 28, 2015 Teva Pharmaceuticals USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016
  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:
Teva Pharmaceuticals USA
Reason for Recall:
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

Product Codes/Lot Numbers:

Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1089-2015

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