FDA recall D-1351-2015

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2015-07-24

Report date

2015-09-02

Termination date

2016-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2015