Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. ...
FDA Recall #D-0553-2024 — Class I — May 28, 2024
Product Description
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
Reason for Recall
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Recalling Firm
Sagent Pharmaceuticals — Schaumburg, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
762 vials
Distribution
Nationwide within the USA.
Code Information
Lot #: F1040001, Exp. Date 12/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated