ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 31317857B, Exp 08/15 31317859B, Exp 12/15 31317920B, Exp 12/15 31317957B, Exp 12/15 31318136B, Exp 12/15 31318138B, Exp 12/15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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: silcone rubber and fluorouracil crystals found floating in solution
- 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), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
Product Codes/Lot Numbers:
Lot # 31317857B, Exp 08/15 31317859B, Exp 12/15 31317920B, Exp 12/15 31317957B, Exp 12/15 31318136B, Exp 12/15 31318138B, Exp 12/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1351-2015
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