FDA-Drug2015-07-15Class I

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

Teva Pharmaceuticals USA
Hazard

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Sold states
Nationwide
Affected count
6195 vials
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief