Teva Pharmaceuticals USA recalls ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by…

Recall date

July 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1351-2015

FDA classification

Class I

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide.

Why it was recalled

Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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).