FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML)
- FLASCO
- May 15, 2015
- Drugs
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 |