Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Recall Number: D-0553-2024

Firm: Sagent Pharmaceuticals

Classification: Class I

Status: Ongoing

Report Date: 20240619

Initiation Date: 20240528

Termination Date:

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08