Reported Jul 15, 2015 · Terminated
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For…
Teva Pharmaceuticals USA
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- 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
- Lot codes and dates
Lot #s: 31317858BExp 11/201531317899B31317906B31317958B31317959B31318103B31318137BExp 12/201531318533BExp 07/2016
- Amount recalled
- 6195 vials
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Using this product could cause serious injury, illness or death — stop using it now.
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