FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML)

teva oncology
  • FLASCO
  • May 15, 2015

FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML)

Teva Parenteral Medicines has issued a voluntary recall of eight lots of fluorouracil injection USP (Adrucil) 5 g/100 mL (50 mg/mL). The reason cited is the potential presence of particulate matter, namely, aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Individual 5 g/100 ml vials have the NDC code 0703-3019-11; the pharmacy shelf pack has the NDC code 0703-3019-12. The 5 g/100 ml vials are also labeled to indicate that the pharmacy bulk package is not for direct infusion.

The recalled lots are as follows: Lot # Exp. Date Vial Size NDC #, Individual NDC #, Carton of Five
31317858B 11/2015 100 mL 0703-3019-11 0703-3019-12
31317899B 12/2015 100 mL 0703-3019-11 0703-3019-12
31317906B 12/2015 100 mL 0703-3019-11 0703-3019-12
31317958B 12/2015 100 mL 0703-3019-11 0703-3019-12
31317959B 12/2015 100 mL 0703-3019-11 0703-3019-12
31318103B 12/2015 100 mL 0703-3019-11 0703-3019-12
31318137B 12/2015 100 mL 0703-3019-11 0703-3019-12
31318533B 7/2016 100 mL 0703-3019-11 0703-3019-12

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