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).