Why it was recalled
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Product 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
Lot numbers, UPCs & expiration codes
Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1089-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 28, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 6195 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1089-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71128
- Address
- 425 Privet Rd
- Code information
- Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016
- Postal code
- 19044-1220
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1089-2015
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 6195 vials
- Termination date
- Nov 4, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2015