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: 31317858B
    • Exp 11/2015
    • 31317899B
    • 31317906B
    • 31317958B
    • 31317959B
    • 31318103B
    • 31318137B
    • Exp 12/2015
    • 31318533B
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 4, 2016 · Data as of Sep 19, 5:01 PM UTC

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