FDA-Drug2015-09-02Class I

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).

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide.
Affected count
6001 vials
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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).

Official notice

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

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