Recall: D-0554-2024

Class I - Dangerous

Class IClassification

2024-05-28Initiated

OngoingStatus

Sagent PharmaceuticalsFirm

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

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

Distribution

Nationwide within the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.