Product: 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).
Reason for recall: Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Recall initiated: 20150724
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated