Why it was recalled
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Product 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).
Lot numbers, UPCs & expiration codes
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
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-1351-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 24, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 6001 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1351-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71799
- Address
- 425 Privet Rd
- Code information
- 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
- Postal code
- 19044-1220
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1351-2015
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 6001 vials
- Termination date
- Nov 2, 2016
- Reason for recall
- Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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).
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2015