Reported Sep 2, 2015 · Terminated
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by…
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), 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).
- Lot codes and dates
Lot # 31317857BExp 08/15 31317859BExp 12/15 31317920BExp 12/15 31317957BExp 12/15 31318136BExp 12/15 31318138BExp 12/15
- Amount recalled
- 6001 vials
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Using this product could cause serious injury, illness or death — stop using it now.
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