Teva Recalls Six Lots of Adrucil for Particulate Matter

Teva Parenteral Medicines has issued a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Adrucil injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages. The pharmacy bulk package has five 5 g/100-mL vials per shelf pack. Adrucil 5 g/100 ml vials were distributed in the United States. Teva has distributed this product nationwide through wholesalers, retailers, and pharmacies.

Source: Teva Parenteral Medicines and FDA

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