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).
Recall Number: D-1351-2015
Firm: Teva Pharmaceuticals USA
Classification: Class I
Status: Terminated
Report Date: 20150902
Initiation Date: 20150724
Termination Date: 20161102
Reason for Recall
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).