Teva Voluntarily Recalls Select Lots of Fluorouracil Injectable
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Teva Parenteral Medicines has announced a voluntary recall of eight 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. To date, Teva has not received any reports of adverse events related to this recall.

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. Adrucil® 5 g/100 mL vials were distributed in the United States. Teva has distributed this product through the normal distribution chain of wholesalers, retailers, and pharmacies.

Source: FDA and Teva Parenteral Medicines

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