Product: Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Reason for recall: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Recall initiated: 20240528
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated