Sagent Pharmaceuticals issued a voluntary recall of two lots of a cancer drug because of a "potential presence of particulate matter," the FDA said May 29.
The recall includes 80 milligrams per 8-milliliter multi-dose vials and 160 milligrams per 16-milliliter multi-dose vials of docetaxel injection. The therapy is indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma, and head and neck squamous cell carcinoma.
If there's a particulate matter in an injectable drug, patients face the risk of serious adverse events, the FDA said.
The particulates were detected in the product's stopper, and to date, Sagent has not received any adverse event reports.